Pancreatic Ductal Adenocarcinoma (PDAC)K4CARE-PDACNCT07597252
ctDNA Monitoring After Pancreatic Cancer Surgery (K-4CARE Lite Study)
An observational study of Pancreatic Ductal Adenocarcinoma (PDAC) and NGS Monitor MRD, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Pancreatic ductal adenocarcinoma (PDAC) carries one of the worst prognoses among solid tumors. Even after curative-intent resection, 70-80% of patients recur within two years. Current post-operative surveillance relies on computed tomography (CT) imaging and the serum tumor marker CA 19-9, but both have limited… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Pancreatic Ductal Adenocarcinoma (PDAC), NGS Monitor MRD
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Sep 2026to 30 Apr 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with histologically confirmed pancreatic ductal adenocarcinoma who underwent R0 or R1 (margin <1 mm) curative resection at Linkou Chang Gung Memorial Hospital, recruited consecutively from the oncology and general surgical outpatient clinics during their post-operative follow-up. No public advertising or open recruitment used.
Who may be able to join
- Age 20 years or older
- Histologically confirmed pancreatic ductal adenocarcinoma (PDAC), including its histological subtypes
- Has undergone curative-intent resection (R0 or R1, defined as margin <1 mm), via pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy
- Post-operative pathologic stage at least pT1, with N0 or N1 or higher
- Computed tomography (CT) or magnetic resonance imaging (MRI) within 4 weeks before enrollment confirming no evidence of residual tumor and no distant metastasis
- Intent to receive adjuvant chemotherapy
Show all 9Show fewer
- Sufficient surgical FFPE tumor tissue available for genomic sequencing
- Able to understand and provide signed informed consent
- Patients with or without prior neoadjuvant chemotherapy are both eligible
Who cannot join
- Post-operative pathologic stage IV (distant metastasis), or R2 resection
- Concurrent active primary malignancy (except cured non-melanoma skin cancer or carcinoma in situ within the past 5 years)
- Severe post-operative complications precluding initiation of adjuvant chemotherapy within 12 weeks
- Receipt of post-operative radiation therapy
- Known hematologic disease or myeloproliferative disorder that may significantly affect ctDNA assay accuracy
- Pregnant or breastfeeding women
- Unable to comply with the protocol-specified blood draw schedule
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
Linkou Chang Gung Memorial Hospital
Taoyuan, Taoyuan, 333
Wen-Kuan Huang, MD,PhD, +886-3-3281200 ext. 2524, medfox0924@cgmh.org.tw
Chun-Nan Yeh, MD, +886-3-3281200 ext. 3219, ycn@cgmh.org.tw
About this study
Official title: A Prospective Observational Study of Circulating Tumor DNA Dynamic Monitoring Using K-4CARE Lite Platform After Curative Resection of Pancreatic Cancer
Pancreatic ductal adenocarcinoma (PDAC) carries one of the worst prognoses among solid tumors. Even after curative-intent resection, 70-80% of patients recur within two years. Current post-operative surveillance relies on computed tomography (CT) imaging and the serum tumor marker CA 19-9, but both have limited sensitivity for detecting microscopic residual disease.
This single-center, prospective observational study evaluates the use of the K-4CARE Lite platform-a tumor-informed plus tumor-agnostic circulating tumor DNA (ctDNA) assay with a limit of detection of 0.005%-for dynamic monitoring of minimal residual disease (MRD) in patients with resected PDAC.
Read more
Thirty adult patients who have undergone R0 or R1 (margin <1 mm) resection at Linkou Chang Gung Memorial Hospital will be enrolled over 24 months. Each participant will provide one baseline tumor tissue sample (formalin-fixed paraffin-embedded) and three serial blood samples at three pre-specified study timepoints: Timepoint 1 (Week 4 to Week 10 after surgery, before adjuvant chemotherapy); Timepoint 2 (12 weeks after Timepoint 1, approximately 3 months into adjuvant chemotherapy); and Timepoint 3 (at completion of adjuvant chemotherapy, approximately Month 6 after surgery). A fourth long-term follow-up phase (Timepoint 4) collects results from patient-funded ctDNA testing performed as part of routine care.
The primary outcome is the cumulative MRD detection rate across the three pre-specified post-surgical timepoints (Timepoint 1, Timepoint 2, and Timepoint 3). Secondary outcomes include the association between ctDNA status and disease-free survival (DFS) and overall survival (OS), molecular clearance rate at Timepoint 3, lead time of molecular relapse over imaging, and platform performance. ctDNA results are reported back to the treating physician for reference but do not mandate treatment changes-all clinical decisions remain at the physician's discretion per standard guidelines.
This study aims to generate the prospective evidence base needed to design future ctDNA-guided interventional trials in pancreatic cancer.
Read the detailed description
BACKGROUND Pancreatic ductal adenocarcinoma (PDAC) is one of the most lethal solid tumors. Even after curative resection, 70-80% of patients relapse within 2 years. Conventional surveillance with CT imaging and serum CA 19-9 detects recurrence only after macroscopic tumor burden has accumulated, missing the window for early intervention. Circulating tumor DNA (ctDNA) has emerged as a sensitive biomarker for minimal residual disease (MRD) in colorectal and lung cancers, but standardized prospective ctDNA monitoring data in pancreatic cancer remain limited.
PLATFORM
K-4CARE Lite (Gene Solutions JSC, Ho Chi Minh City, Vietnam) is a comprehensive genomic profiling platform combining:
- 515-gene DNA panel for baseline tissue profiling
- Up to 50 personalized tumor-informed tracking variants for liquid biopsy
- 113-gene gastrointestinal tumor-agnostic panel as a parallel tumor-agnostic track
- Hybrid capture sequencing at 5,000-10,000X depth on plasma, 200X on tissue
- Limit of detection: 0.005% variant allele frequency (VAF)
- Buffy coat / white blood cell sequencing in parallel to filter clonal hematopoiesis of indeterminate potential (CHIP) and germline variants
- Reports homologous recombination deficiency (HRD), tumor mutational burden (TMB), microsatellite instability (MSI) status
- First report turnaround: approximately 6 days
DESIGN Single-center, prospective, non-interventional observational cohort study at Linkou Chang Gung Memorial Hospital. ctDNA results are returned to the treating physician for reference but do not mandate any treatment change; all therapeutic decisions follow standard adjuvant chemotherapy practice and physician discretion.
POPULATION N = 30 adults (aged 20 years or older) with histologically confirmed PDAC who have undergone R0 or R1 (margin close <1 mm) curative resection (pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy), with post-operative pathologic stage at least pT1 N0 or any N1+, no radiologic evidence of residual or distant disease within 4 weeks before enrollment, and intent to receive adjuvant chemotherapy.
SAMPLING TIMELINE
- Screening: Week 4 to Week 12 after surgery; informed consent
- Baseline: Formalin-fixed paraffin-embedded (FFPE) tumor tissue and buffy coat (drawn at Timepoint 1)
- Timepoint 1 (mandatory): Week 4 to Week 10 after surgery, before first adjuvant chemotherapy dose; 20 mL whole blood
- Timepoint 2 (mandatory): 12 weeks after Timepoint 1 (approximately 3 months into chemotherapy); 20 mL whole blood
- Timepoint 3 (mandatory): At completion of adjuvant chemotherapy or premature termination (approximately Month 6 after surgery); 20 mL whole blood
- Timepoint 4 (passive data collection only): Long-term follow-up after Timepoint 3; the study does not arrange or fund ctDNA testing in this phase. If a participant elects to undergo ctDNA testing as part of self-funded routine care, the study collects those results.
PRIMARY OUTCOME Cumulative MRD detection rate across the three pre-specified post-surgical timepoints (Timepoint 1, Timepoint 2, and Timepoint 3), defined as the proportion of participants with at least one tracking mutation detected at variant allele frequency above the K-4CARE Lite platform's limit of detection at one or more timepoints.
SECONDARY OUTCOMES
- Disease-free survival (DFS): From surgery to first radiologic or pathologic recurrence or death from any cause
- Overall survival (OS): From surgery to death from any cause
- Molecular clearance rate at Timepoint 3: Proportion of participants with negative ctDNA result at Timepoint 3 (newly cleared or persistently negative)
- Lead time of molecular relapse: Interval from first ctDNA conversion (negative to positive) to radiologic recurrence
- VAF kinetics from Timepoint 1 through Timepoint 3 (slope: rising, falling, stable)
- Platform performance: Assay success rate and turnaround time from sample receipt to report
- Single-timepoint MRD detection rate at Timepoint 1 (reported separately for cross-study comparison with prior single-timepoint PDAC ctDNA literature)
EXPLORATORY OUTCOMES
- Correlation of baseline HRD, TMB, and MSI with ctDNA dynamics
- Concordance of ctDNA monitoring with CA 19-9 trajectory (Cohen's kappa)
- Frequency and types of newly emerging resistance mutations during follow-up
STATISTICAL METHODS Primarily descriptive. MRD detection rate reported as percentage with 95% Wilson confidence interval. Survival analyses by Kaplan-Meier with log-rank tests, exploratory given the limited sample size. Categorical comparisons by Fisher's exact test. Continuous comparisons by Wilcoxon rank-sum test. Cox proportional hazards regression limited to 2 to 3 covariates given the sample size. Analyses in R (version 4.0 or higher) or SAS (version 9.4 or higher); two-sided p < 0.05. Missing data not imputed.
FUNDING Timepoint 1 through Timepoint 3 ctDNA testing is funded by the principal investigator's intramural Body of Medical Research Project (BMRP) grant from Chang Gung Memorial Hospital. Gene Solutions provides the testing service only and has no role in study design, data analysis, or publication decisions. Timepoint 4 self-funded testing by participants is not reimbursed by the study.
SAMPLE LOGISTICS Samples are received in Taiwan at NEWCL and forwarded to Gene Solutions JSC, Ho Chi Minh City, Vietnam, for sequencing. Specimens carry a study code only; no identifiable patient information accompanies the sample.
- Keywords
- pancreatic cancer, circulating tumor DNA, minimal residual disease, tumor-informed sequencing, adjuvant chemotherapy, liquid biopsy, K-4CARE Lite
- Medical subject headings
- Pancreatic Neoplasms, Neoplasm, Residual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Resected PDAC patients undergoing adjuvant chemotherapy | Adults with histologically confirmed pancreatic ductal adenocarcinoma who have undergone R0 or R1 (margin <1 mm) curative resection at Linkou Chang Gung Memorial Hospital, with intent to receive adjuvant chemotherapy. All participants follow the same ctDNA monitoring schedule (Timepoint 1, Timepoint 2, and Timepoint 3 are mandatory; Timepoint 4 is passive data collection from self-funded testing). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative Minimal Residual Disease (MRD) Detection Rate Across Three Post-Surgical Timepoints
The proportion of participants with circulating tumor DNA (ctDNA) detected at one or more of the three pre-specified post-surgical surveillance timepoints (Timepoint 1, Timepoint 2, or Timepoint 3). A timepoint is classified as ctDNA-positive if at least one tracking mutation is detected at variant allele frequency above the K-4CARE Lite platform's limit of detection (0.005%). Pancreatic ductal adenocarcinoma is recognized as a moderate-to-low ctDNA shedder, with reported single-timepoint post-resection detection rates of 30-60%; cumulative detection across serial timepoints is hypothesized to improve sensitivity for assay-defined minimal residual disease. Reported as percentage with 95% Wilson confidence interval, with stratified contribution by individual timepoint.
Measured: From Timepoint 1 (Week 4 to Week 10 after surgery) through Timepoint 3 (approximately Month 6 after surgery, at completion of adjuvant chemotherapy), spanning up to 8 months per participant.
Secondary outcomes (5)
ctDNA Molecular Clearance Rate at Timepoint 3 (End of Adjuvant Chemotherapy)
Proportion of participants with negative ctDNA result at Timepoint 3 (no tracking mutation detected above the limit of detection), regardless of Timepoint 1 or Timepoint 2 status. Includes both newly cleared participants (positive at Timepoint 1, negative at Timepoint 3) and persistently negative participants.
Measured: At Timepoint 3, defined as completion of adjuvant chemotherapy (approximately Month 6 after surgery) or earlier termination.
ctDNA Variant Allele Frequency (VAF) Kinetics During Adjuvant Treatment
For each participant, the slope of the highest variant allele frequency (VAF) of any tracking mutation is computed for up to two intervals: (a) Timepoint 1 to Timepoint 2 (intra-treatment, approximately 12 weeks apart, capturing early response to adjuvant chemotherapy); and (b) Timepoint 1 to Timepoint 3 (full-course, approximately 6-month span, capturing end-of-treatment status). Each interval is categorized as rising (2-fold or greater VAF increase), falling (2-fold or greater decrease), stable (no 2-fold or greater change between detectable values), undetectable-throughout (negative at both timepoints), or new emergence (negative at Timepoint 1, converting to positive at Timepoint 2 or Timepoint 3). Reported per-participant per-interval; aggregate distribution reported as proportions, with sub-analysis comparing Timepoint 1-to-Timepoint 2 versus Timepoint 1-to-Timepoint 3 trajectories. Participants missing one of the two later timepoints contribute only the available interval.
Measured: From Timepoint 1 (Week 4 to Week 10 after surgery) through Timepoint 3 (approximately Month 6 after surgery, at completion of adjuvant chemotherapy), spanning up to 8 months per participant.
Disease-Free Survival (DFS)
Time from date of curative surgery to the first radiologically or pathologically confirmed disease recurrence, or death from any cause, whichever occurs first. Estimated by Kaplan-Meier method; participants without recurrence or death are censored at the date of last disease assessment. Stratified analysis comparing ctDNA-positive versus ctDNA-negative participants at Timepoint 1 by log-rank test.
Measured: From date of surgery up to Month 36 (last enrolled participant followed for at least 12 months after Timepoint 3)
Overall Survival (OS)
Time from date of curative surgery to death from any cause. Participants alive at the data cut-off are censored at last known alive date. Estimated by Kaplan-Meier method.
Measured: From date of surgery up to Month 36.
Lead Time of Molecular Relapse Over Imaging
Interval (in days) between the date of first ctDNA conversion from negative to positive (during the monitoring window spanning Timepoint 2 through Timepoint 4) and the date of radiologically confirmed disease recurrence. Reported as median with interquartile range among participants who experience both ctDNA conversion and imaging recurrence.
Measured: From Timepoint 1 (Week 4 to Week 10 after surgery) to end of follow-up, up to Month 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start1 Sep 2026 (estimated)
- Primary completion30 Apr 2029 (estimated)
- Study completion30 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Pancreatic Ductal Adenocarcinoma (PDAC)Studies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, WenKuan Huang, MD, PhD, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07597252
- Sponsor's protocol ID
- K4CARE-Lite-PDAC-2026
- Other IDs
- Chang Gung Memorial Hospital
- Acronym
- K4CARE-PDAC
- Status last verified
- Jul 2026
- First submitted
- 9 May 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to the limited sample size and the sensitive nature of genomic sequencing data. De-identified summary results will be reported in peer-reviewed publications and at scientific conferences.
Publications
Pascual J, Attard G, Bidard FC, Curigliano G, De Mattos-Arruda L, Diehn M, Italiano A, Lindberg J, Merker JD, Montagut C, Normanno N, Pantel K, Pentheroudakis G, Popat S, Reis-Filho JS, Tie J, Seoane J, Tarazona N, Yoshino T, Turner NC. ESMO recommendations on the use of circulating tumour DNA assays for patients with cancer: a report from the ESMO Precision Medicine Working Group. Ann Oncol. 2022 Aug;33(8):750-768. doi: 10.1016/j.annonc.2022.05.520. Epub 2022 Jul 6.
PubMed 35809752Conroy T, Hammel P, Hebbar M, Ben Abdelghani M, Wei AC, Raoul JL, Chone L, Francois E, Artru P, Biagi JJ, Lecomte T, Assenat E, Faroux R, Ychou M, Volet J, Sauvanet A, Breysacher G, Di Fiore F, Cripps C, Kavan P, Texereau P, Bouhier-Leporrier K, Khemissa-Akouz F, Legoux JL, Juzyna B, Gourgou S, O'Callaghan CJ, Jouffroy-Zeller C, Rat P, Malka D, Castan F, Bachet JB; Canadian Cancer Trials Group and the Unicancer-GI-PRODIGE Group. FOLFIRINOX or Gemcitabine as Adjuvant Therapy for Pancreatic Cancer. N Engl J Med. 2018 Dec 20;379(25):2395-2406. doi: 10.1056/NEJMoa1809775.
PubMed 30575490Kobayashi S, Nakamura Y, Hashimoto T, Bando H, Oki E, Karasaki T, Horinouchi H, Ozaki Y, Iwata H, Kato T, Miyake H, Ohba A, Ikeda M, Chiyoda T, Hasegawa K, Fujisawa T, Matsuura K, Namikawa K, Yajima S, Yoshino T, Hasegawa K. Japan society of clinical oncology position paper on appropriate clinical use of molecular residual disease (MRD) testing. Int J Clin Oncol. 2025 Apr;30(4):605-654. doi: 10.1007/s10147-024-02683-0. Epub 2025 Feb 7.
PubMed 39920551Borges FC, Pinto MS, Borges MF, Joao AA, Francisco E, Sousa M, Aral M, Oliveira V, Cunha JF, Mehrabi A, Berchtold C, Goncalves G, Bailey P, Buchler MW. The Role of Circulating Tumor DNA in Surgical Management of Pancreatic Cancer: Systematic Review and Meta-analysis. Ann Surg. 2026 Feb 16. doi: 10.1097/SLA.0000000000007036. Online ahead of print.
PubMed 41696920Bernard V, Kim DU, San Lucas FA, Castillo J, Allenson K, Mulu FC, Stephens BM, Huang J, Semaan A, Guerrero PA, Kamyabi N, Zhao J, Hurd MW, Koay EJ, Taniguchi CM, Herman JM, Javle M, Wolff R, Katz M, Varadhachary G, Maitra A, Alvarez HA. Circulating Nucleic Acids Are Associated With Outcomes of Patients With Pancreatic Cancer. Gastroenterology. 2019 Jan;156(1):108-118.e4. doi: 10.1053/j.gastro.2018.09.022. Epub 2018 Sep 19.
PubMed 30240661Pietrasz D, Pecuchet N, Garlan F, Didelot A, Dubreuil O, Doat S, Imbert-Bismut F, Karoui M, Vaillant JC, Taly V, Laurent-Puig P, Bachet JB. Plasma Circulating Tumor DNA in Pancreatic Cancer Patients Is a Prognostic Marker. Clin Cancer Res. 2017 Jan 1;23(1):116-123. doi: 10.1158/1078-0432.CCR-16-0806. Epub 2016 Dec 19.
PubMed 27993964Lee B, Lipton L, Cohen J, Tie J, Javed AA, Li L, Goldstein D, Burge M, Cooray P, Nagrial A, Tebbutt NC, Thomson B, Nikfarjam M, Harris M, Haydon A, Lawrence B, Tai DWM, Simons K, Lennon AM, Wolfgang CL, Tomasetti C, Papadopoulos N, Kinzler KW, Vogelstein B, Gibbs P. Circulating tumor DNA as a potential marker of adjuvant chemotherapy benefit following surgery for localized pancreatic cancer. Ann Oncol. 2019 Sep 1;30(9):1472-1478. doi: 10.1093/annonc/mdz200.
PubMed 31250894Groot VP, Mosier S, Javed AA, Teinor JA, Gemenetzis G, Ding D, Haley LM, Yu J, Burkhart RA, Hasanain A, Debeljak M, Kamiyama H, Narang A, Laheru DA, Zheng L, Lin MT, Gocke CD, Fishman EK, Hruban RH, Goggins MG, Molenaar IQ, Cameron JL, Weiss MJ, Velculescu VE, He J, Wolfgang CL, Eshleman JR. Circulating Tumor DNA as a Clinical Test in Resected Pancreatic Cancer. Clin Cancer Res. 2019 Aug 15;25(16):4973-4984. doi: 10.1158/1078-0432.CCR-19-0197. Epub 2019 May 29.
PubMed 31142500
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study of Circulating Tumor DNA Dynamic Monitoring Using K-4CARE Lite Platform After Curative Resection of Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT07597252
- Acronym / sponsor ID
- K4CARE-PDAC / K4CARE-Lite-PDAC-2026
- Keywords
- pancreatic cancer, circulating tumor DNA, minimal residual disease, tumor-informed sequencing, adjuvant chemotherapy, liquid biopsy, K-4CARE Lite
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Apr 2029 (estimated)
- Study completion
- 30 Apr 2029 (estimated)
- First posted
- 19 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pancreatic ductal adenocarcinoma (PDAC) carries one of the worst prognoses among solid tumors. Even after curative-intent resection, 70-80% of patients recur within two years. Current post-operative surveillance relies on computed tomography (CT) imaging and the serum tumor marker CA 19-9, but both have limited sensitivity for detecting microscopic residual disease.
This single-center, prospective observational study evaluates the use of the K-4CARE Lite platform-a tumor-informed plus tumor-agnostic circulating tumor DNA (ctDNA) assay with a limit of detection of 0.005%-for dynamic monitoring of minimal residual disease (MRD) in patients with resected PDAC.
Thirty adult patients who have undergone R0 or R1 (margin <1 mm) resection at Linkou Chang Gung Memorial Hospital will be enrolled over 24 months. Each participant will provide one baseline tumor tissue sample (formalin-fixed paraffin-embedded) and three serial blood samples at three pre-specified study timepoints: Timepoint 1 (Week 4 to Week 10 after surgery, before adjuvant chemotherapy); Timepoint 2 (12 weeks after Timepoint 1, approximately 3 months into adjuvant chemotherapy); and Timepoint 3 (at completion of adjuvant chemotherapy, approximately Month 6 after surgery). A fourth long-term follow-up phase (Timepoint 4) collects results from patient-funded ctDNA testing performed as part of routine care.
The primary outcome is the cumulative MRD detection rate across the three pre-specified post-surgical timepoints (Timepoint 1, Timepoint 2, and Timepoint 3). Secondary outcomes include the association between ctDNA status and disease-free survival (DFS) and overall survival (OS), molecular clearance rate at Timepoint 3, lead time of molecular relapse over imaging, and platform performance. ctDNA results are reported back to the treating physician for reference but do not mandate treatment changes-all clinical decisions remain at the physician's discretion per standard guidelines.
This study aims to generate the prospective evidence base needed to design future ctDNA-guided interventional trials in pancreatic cancer.
Detailed description
BACKGROUND Pancreatic ductal adenocarcinoma (PDAC) is one of the most lethal solid tumors. Even after curative resection, 70-80% of patients relapse within 2 years. Conventional surveillance with CT imaging and serum CA 19-9 detects recurrence only after macroscopic tumor burden has accumulated, missing the window for early intervention. Circulating tumor DNA (ctDNA) has emerged as a sensitive biomarker for minimal residual disease (MRD) in colorectal and lung cancers, but standardized prospective ctDNA monitoring data in pancreatic cancer remain limited.
PLATFORM
K-4CARE Lite (Gene Solutions JSC, Ho Chi Minh City, Vietnam) is a comprehensive genomic profiling platform combining:
- 515-gene DNA panel for baseline tissue profiling
- Up to 50 personalized tumor-informed tracking variants for liquid biopsy
- 113-gene gastrointestinal tumor-agnostic panel as a parallel tumor-agnostic track
- Hybrid capture sequencing at 5,000-10,000X depth on plasma, 200X on tissue
- Limit of detection: 0.005% variant allele frequency (VAF)
- Buffy coat / white blood cell sequencing in parallel to filter clonal hematopoiesis of indeterminate potential (CHIP) and germline variants
- Reports homologous recombination deficiency (HRD), tumor mutational burden (TMB), microsatellite instability (MSI) status
- First report turnaround: approximately 6 days
DESIGN Single-center, prospective, non-interventional observational cohort study at Linkou Chang Gung Memorial Hospital. ctDNA results are returned to the treating physician for reference but do not mandate any treatment change; all therapeutic decisions follow standard adjuvant chemotherapy practice and physician discretion.
POPULATION N = 30 adults (aged 20 years or older) with histologically confirmed PDAC who have undergone R0 or R1 (margin close <1 mm) curative resection (pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy), with post-operative pathologic stage at least pT1 N0 or any N1+, no radiologic evidence of residual or distant disease within 4 weeks before enrollment, and intent to receive adjuvant chemotherapy.
SAMPLING TIMELINE
- Screening: Week 4 to Week 12 after surgery; informed consent
- Baseline: Formalin-fixed paraffin-embedded (FFPE) tumor tissue and buffy coat (drawn at Timepoint 1)
- Timepoint 1 (mandatory): Week 4 to Week 10 after surgery, before first adjuvant chemotherapy dose; 20 mL whole blood
- Timepoint 2 (mandatory): 12 weeks after Timepoint 1 (approximately 3 months into chemotherapy); 20 mL whole blood
- Timepoint 3 (mandatory): At completion of adjuvant chemotherapy or premature termination (approximately Month 6 after surgery); 20 mL whole blood
- Timepoint 4 (passive data collection only): Long-term follow-up after Timepoint 3; the study does not arrange or fund ctDNA testing in this phase. If a participant elects to undergo ctDNA testing as part of self-funded routine care, the study collects those results.
PRIMARY OUTCOME Cumulative MRD detection rate across the three pre-specified post-surgical timepoints (Timepoint 1, Timepoint 2, and Timepoint 3), defined as the proportion of participants with at least one tracking mutation detected at variant allele frequency above the K-4CARE Lite platform's limit of detection at one or more timepoints.
SECONDARY OUTCOMES
- Disease-free survival (DFS): From surgery to first radiologic or pathologic recurrence or death from any cause
- Overall survival (OS): From surgery to death from any cause
- Molecular clearance rate at Timepoint 3: Proportion of participants with negative ctDNA result at Timepoint 3 (newly cleared or persistently negative)
- Lead time of molecular relapse: Interval from first ctDNA conversion (negative to positive) to radiologic recurrence
- VAF kinetics from Timepoint 1 through Timepoint 3 (slope: rising, falling, stable)
- Platform performance: Assay success rate and turnaround time from sample receipt to report
- Single-timepoint MRD detection rate at Timepoint 1 (reported separately for cross-study comparison with prior single-timepoint PDAC ctDNA literature)
EXPLORATORY OUTCOMES
- Correlation of baseline HRD, TMB, and MSI with ctDNA dynamics
- Concordance of ctDNA monitoring with CA 19-9 trajectory (Cohen's kappa)
- Frequency and types of newly emerging resistance mutations during follow-up
STATISTICAL METHODS Primarily descriptive. MRD detection rate reported as percentage with 95% Wilson confidence interval. Survival analyses by Kaplan-Meier with log-rank tests, exploratory given the limited sample size. Categorical comparisons by Fisher's exact test. Continuous comparisons by Wilcoxon rank-sum test. Cox proportional hazards regression limited to 2 to 3 covariates given the sample size. Analyses in R (version 4.0 or higher) or SAS (version 9.4 or higher); two-sided p < 0.05. Missing data not imputed.
FUNDING Timepoint 1 through Timepoint 3 ctDNA testing is funded by the principal investigator's intramural Body of Medical Research Project (BMRP) grant from Chang Gung Memorial Hospital. Gene Solutions provides the testing service only and has no role in study design, data analysis, or publication decisions. Timepoint 4 self-funded testing by participants is not reimbursed by the study.
SAMPLE LOGISTICS Samples are received in Taiwan at NEWCL and forwarded to Gene Solutions JSC, Ho Chi Minh City, Vietnam, for sequencing. Specimens carry a study code only; no identifiable patient information accompanies the sample.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Resected PDAC patients undergoing adjuvant chemotherapy | – | –Adults with histologically confirmed pancreatic ductal adenocarcinoma who have undergone R0 or R1 (margin <1 mm) curative resection at Linkou Chang Gung Memorial Hospital, with intent to receive adjuvant chemotherapy. All participants follow the same ctDNA monitoring schedule (Timepoint 1, Timepoint 2, and Timepoint 3 are mandatory; Timepoint 4 is passive data collection from self-funded testing). |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with histologically confirmed pancreatic ductal adenocarcinoma who underwent R0 or R1 (margin <1 mm) curative resection at Linkou Chang Gung Memorial Hospital, recruited consecutively from the oncology and general surgical outpatient clinics during their post-operative follow-up. No public advertising or open recruitment used.
Key inclusion criteria (9 listed)
- Age 20 years or older
- Histologically confirmed pancreatic ductal adenocarcinoma (PDAC), including its histological subtypes
- Has undergone curative-intent resection (R0 or R1, defined as margin <1 mm), via pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy
- Post-operative pathologic stage at least pT1, with N0 or N1 or higher
- Computed tomography (CT) or magnetic resonance imaging (MRI) within 4 weeks before enrollment confirming no evidence of residual tumor and no distant metastasis
Key exclusion criteria (7 listed)
- Post-operative pathologic stage IV (distant metastasis), or R2 resection
- Concurrent active primary malignancy (except cured non-melanoma skin cancer or carcinoma in situ within the past 5 years)
- Severe post-operative complications precluding initiation of adjuvant chemotherapy within 12 weeks
- Receipt of post-operative radiation therapy
- Known hematologic disease or myeloproliferative disorder that may significantly affect ctDNA assay accuracy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cumulative Minimal Residual Disease (MRD) Detection Rate Across Three Post-Surgical Timepoints
Time frame: From Timepoint 1 (Week 4 to Week 10 after surgery) through Timepoint 3 (approximately Month 6 after surgery, at completion of adjuvant chemotherapy), spanning up to 8 months per participant.
The proportion of participants with circulating tumor DNA (ctDNA) detected at one or more of the three pre-specified post-surgical surveillance timepoints (Timepoint 1, Timepoint 2, or Timepoint 3). A timepoint is classified as ctDNA-positive if at least one tracking mutation is detected at variant allele frequency above the K-4CARE Lite platform's limit of detection (0.005%). Pancreatic ductal adenocarcinoma is recognized as a moderate-to-low ctDNA shedder, with reported single-timepoint post-resection detection rates of 30-60%; cumulative detection across serial timepoints is hypothesized to improve sensitivity for assay-defined minimal residual disease. Reported as percentage with 95% Wilson confidence interval, with stratified contribution by individual timepoint.
5 secondary outcomes
ctDNA Molecular Clearance Rate at Timepoint 3 (End of Adjuvant Chemotherapy)
Time frame: At Timepoint 3, defined as completion of adjuvant chemotherapy (approximately Month 6 after surgery) or earlier termination.
ctDNA Variant Allele Frequency (VAF) Kinetics During Adjuvant Treatment
Time frame: From Timepoint 1 (Week 4 to Week 10 after surgery) through Timepoint 3 (approximately Month 6 after surgery, at completion of adjuvant chemotherapy), spanning up to 8 months per participant.
Disease-Free Survival (DFS)
Time frame: From date of surgery up to Month 36 (last enrolled participant followed for at least 12 months after Timepoint 3)
Overall Survival (OS)
Time frame: From date of surgery up to Month 36.
Lead Time of Molecular Relapse Over Imaging
Time frame: From Timepoint 1 (Week 4 to Week 10 after surgery) to end of follow-up, up to Month 36
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Background: PubMed 35809752Pascual J, Attard G, Bidard FC, Curigliano G, De Mattos-Arruda L, Diehn M, Italiano A, Lindberg J, Merker JD, Montagut C, Normanno N, Pantel K, Pentheroudakis G, Popat S, Reis-Filho JS, Tie J, Seoane J, Tarazona N, Yoshino T, Turner NC. ESMO recommendations on the use of circulating tumour DNA assays for patients with cancer: a report from the ESMO Precision Medicine Working Group. Ann Oncol. 2022 Aug;33(8):750-768. doi: 10.1016/j.annonc.2022.05.520. Epub 2022 Jul 6.
- Background: PubMed 30575490Conroy T, Hammel P, Hebbar M, Ben Abdelghani M, Wei AC, Raoul JL, Chone L, Francois E, Artru P, Biagi JJ, Lecomte T, Assenat E, Faroux R, Ychou M, Volet J, Sauvanet A, Breysacher G, Di Fiore F, Cripps C, Kavan P, Texereau P, Bouhier-Leporrier K, Khemissa-Akouz F, Legoux JL, Juzyna B, Gourgou S, O'Callaghan CJ, Jouffroy-Zeller C, Rat P, Malka D, Castan F, Bachet JB; Canadian Cancer Trials Group and the Unicancer-GI-PRODIGE Group. FOLFIRINOX or Gemcitabine as Adjuvant Therapy for Pancreatic Cancer. N Engl J Med. 2018 Dec 20;379(25):2395-2406. doi: 10.1056/NEJMoa1809775.
- Background: PubMed 39920551Kobayashi S, Nakamura Y, Hashimoto T, Bando H, Oki E, Karasaki T, Horinouchi H, Ozaki Y, Iwata H, Kato T, Miyake H, Ohba A, Ikeda M, Chiyoda T, Hasegawa K, Fujisawa T, Matsuura K, Namikawa K, Yajima S, Yoshino T, Hasegawa K. Japan society of clinical oncology position paper on appropriate clinical use of molecular residual disease (MRD) testing. Int J Clin Oncol. 2025 Apr;30(4):605-654. doi: 10.1007/s10147-024-02683-0. Epub 2025 Feb 7.
- Background: PubMed 41696920Borges FC, Pinto MS, Borges MF, Joao AA, Francisco E, Sousa M, Aral M, Oliveira V, Cunha JF, Mehrabi A, Berchtold C, Goncalves G, Bailey P, Buchler MW. The Role of Circulating Tumor DNA in Surgical Management of Pancreatic Cancer: Systematic Review and Meta-analysis. Ann Surg. 2026 Feb 16. doi: 10.1097/SLA.0000000000007036. Online ahead of print.
- Background: PubMed 30240661Bernard V, Kim DU, San Lucas FA, Castillo J, Allenson K, Mulu FC, Stephens BM, Huang J, Semaan A, Guerrero PA, Kamyabi N, Zhao J, Hurd MW, Koay EJ, Taniguchi CM, Herman JM, Javle M, Wolff R, Katz M, Varadhachary G, Maitra A, Alvarez HA. Circulating Nucleic Acids Are Associated With Outcomes of Patients With Pancreatic Cancer. Gastroenterology. 2019 Jan;156(1):108-118.e4. doi: 10.1053/j.gastro.2018.09.022. Epub 2018 Sep 19.
- Background: PubMed 27993964Pietrasz D, Pecuchet N, Garlan F, Didelot A, Dubreuil O, Doat S, Imbert-Bismut F, Karoui M, Vaillant JC, Taly V, Laurent-Puig P, Bachet JB. Plasma Circulating Tumor DNA in Pancreatic Cancer Patients Is a Prognostic Marker. Clin Cancer Res. 2017 Jan 1;23(1):116-123. doi: 10.1158/1078-0432.CCR-16-0806. Epub 2016 Dec 19.
- Background: PubMed 31250894Lee B, Lipton L, Cohen J, Tie J, Javed AA, Li L, Goldstein D, Burge M, Cooray P, Nagrial A, Tebbutt NC, Thomson B, Nikfarjam M, Harris M, Haydon A, Lawrence B, Tai DWM, Simons K, Lennon AM, Wolfgang CL, Tomasetti C, Papadopoulos N, Kinzler KW, Vogelstein B, Gibbs P. Circulating tumor DNA as a potential marker of adjuvant chemotherapy benefit following surgery for localized pancreatic cancer. Ann Oncol. 2019 Sep 1;30(9):1472-1478. doi: 10.1093/annonc/mdz200.
- Background: PubMed 31142500Groot VP, Mosier S, Javed AA, Teinor JA, Gemenetzis G, Ding D, Haley LM, Yu J, Burkhart RA, Hasanain A, Debeljak M, Kamiyama H, Narang A, Laheru DA, Zheng L, Lin MT, Gocke CD, Fishman EK, Hruban RH, Goggins MG, Molenaar IQ, Cameron JL, Weiss MJ, Velculescu VE, He J, Wolfgang CL, Eshleman JR. Circulating Tumor DNA as a Clinical Test in Resected Pancreatic Cancer. Clin Cancer Res. 2019 Aug 15;25(16):4973-4984. doi: 10.1158/1078-0432.CCR-19-0197. Epub 2019 May 29.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to the limited sample size and the sensitive nature of genomic sequencing data. De-identified summary results will be reported in peer-reviewed publications and at scientific conferences.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Ductal Adenocarcinoma (PDAC) and NGS Monitor MRD, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wen-Kuan Huang, MD,PhD (886-3-3281200 ext. 2524, medfox0924@cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative Minimal Residual Disease (MRD) Detection Rate Across Three Post-Surgical Timepoints (time frame: From Timepoint 1 (Week 4 to Week 10 after surgery) through Timepoint 3 (approximately Month 6 after surgery, at completion of adjuvant chemotherapy), spanning up to 8 months per participant.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07597252, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.