Pancreatic Ductal AdenocarcinomaNCT06151691
Assessment of Early Pancreatic Cancer Prognosis by Minimal Residual Disease Using Multi-omics Approach
An observational study of Pancreatic Ductal Adenocarcinoma, run by Fudan University at 1 site in China.
Trial summary
This trial aims to develop a minimal residual disease (MRD) detection model for predicting recurrence of patients with stage I-II pancreatic ductal adenocarcinoma after surgery and adjuvant therapy, based on cfDNA fragmentation and methylation signal. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Pancreatic Ductal Adenocarcinoma
- What is being tested?
- Blood collection and Pancreatic ductal adenocarcinoma minimal residual disease detection test
- How many people
- 51 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2023to 30 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Eligible participants will be recruited from clinic and medical centers. Participants are defined as new diagnosis cancer patients with pancreatic ductal adenocarcinoma. Demographic and cancer risk-related characteristics (eg, age, gender, smoking status, diabetes) will be collected from all enrolled subjects.
Who may be able to join
- Patients with clinically and/or pathologically diagnosis of stage I/II pancreatic ductal adenocarcinoma;
- Aged ≥ 40 years and < 75 years, both sexes;
- Patients receive radical resection with curative intent, followed by adjuvant therapy;
- Tumour size not less than 1 cm * 1 cm * 1 cm and be able to provide surgical tissue samples for molecular testing after pathological evaluation;
- Eastern Cooperative Oncology Group (ECOG) score of 0-2;
- Negative margins (R0 or R1) by naked eye or no recurrence/metastasis detected on imaging after surgery or before adjuvant therapy, and CA 19-9<37 U/ml;
- Patients understand and voluntarily sign the informed consent form and follow the sampling, assessment and visit requirements of this study.
Who cannot join
- Pregnant and lactating (by self-report);
- Any tumor history of malignancies;
- Positive cutting margins (R2);
- Received neoadjuvant therapy before surgery;
- Not be able to receive radical surgery;
- Organ transplantation history;
- Organ dysfunction (moderate or severe renal impairment with absolute centrocyte count < 1.0 x 10^9/L, platelet count < 75 x 10^9/L, haemoglobin < 80 g/L, AST/ALT > 2.5 times upper limit of normal);
- Other conditions deemed unsuitable for enrollment by the investigator.
Trial locations and contacts
1 site in 1 country.
Si Shi, M.D., Ph.D. contact
China1 site
Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University; 270 Dong An Road, Shanghai 200032, China
Shanghai, 200032
About this study
Official title: Explorations of Cell-free DNA Multi-omics Technology in Detection of Minimal Residual Disease and Disease Prognosis After Surgery in Early Pancreatic Ductal Adenocarcinoma: A Single-center, Prospective, Observational Case Study
This trial aims to develop a minimal residual disease (MRD) detection model for predicting recurrence of patients with stage I-II pancreatic ductal adenocarcinoma after surgery and adjuvant therapy, based on cfDNA fragmentation and methylation signal.
Read the detailed description
The entire study is divided into two stages. Stage one is the enrollment period. 51 subjects with pancreatic ductal adenocarcinoma in stages I-II who have not received neoadjuvant therapy and have undergone radical surgery were enrolled. Blood samples at the time point before surgical treatment (T0) were collected and fresh tissue specimens (cancerous tissue and adjacent normal tissue) were collected. Blood samples were subjected to methylation, fragment group, and CNV multi-omics testing, and tissue samples were subjected to target methylation area testing. Stage two is the follow-up period. Blood samples from the fifth week after surgery to before adjuvant therapy (T1) and blood samples from 4-8 weeks after adjuvant therapy (T2) were collected. Blood samples were subjected to methylation, fragment group, and CNV multi-omics testing with different techniques. The subjects were followed up for 1.5 years. According to progression and recurrence, the subjects were divided into progression group and non-progression group. Methylation and multi-omics prognosis models were trained and compared for their performance in residual detection and recurrence prediction.
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Being tested
- Blood collection and Pancreatic ductal adenocarcinoma minimal residual disease detection test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood collection and Pancreatic ductal adenocarcinoma minimal residual disease detection testOther
Blood samples of participants meet the inclusion/exclusion criteria will be collected.
Pancreatic ductal adenocarcinoma minimal residual disease detection test.
| Study group | Role | What they receive |
|---|---|---|
| Case-Cancer arm | Blood collection and Pancreatic ductal adenocarcinoma minimal residual disease detection test Receives: Other: Blood collection and Pancreatic ductal adenocarcinoma minimal residual disease detection test |
What is being measured
The primary outcome is the main question the study is designed to answer.
1.5-year disease-free survival
1.5-year disease-free survival of patients with pancreatic ductal adenocarcinoma receiving post-operative adjuvant chemotherapy.
Measured: 18 months
Secondary outcomes (4)
Sensitivity of the multi-omics prognostic model
Sensitivity of the multi-omics prognostic model for pancreatic ductal adenocarcinoma based on cfDNA methylation, fragmentation group, and CNV features in patients with recurrence at 95% confidence interval
Measured: 18 months
Specificity of the multi-omics prognostic model
Specificity of the multi-omics prognostic model for pancreatic ductal adenocarcinoma patients without recurrence at 95% confidence intervals.
Measured: 18 months
Area under the receiver operating characteristic curve (AUROC) of the multi-omics prognostic model
Area under the receiver operating characteristic curve (AUROC) of the multi-omics prognostic model for predicting patient recurrence of pancreatic ductal adenocarcinoma at 95% confidence intervals.
Measured: 18 months
Sensitivity of the multi-omics prognostic model in different subgroups
Sensitivity of the multi-omics prognostic model for predicting pancreatic ductal adenocarcinoma recurrence in different subgroups (age, underlying medical history, tumour differentiation, tumour diameter, etc.) at 95% confidence intervals.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2023
- Study start1 Dec 2023 (estimated)
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Ductal AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Weihe Medical Laboratory Co., Ltd.
- Responsible party
- Principal investigator, Xian-Jun Yu, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06151691
- Sponsor's protocol ID
- PC-MRD
- Status last verified
- Nov 2023
- First submitted
- 22 Nov 2023
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Explorations of Cell-free DNA Multi-omics Technology in Detection of Minimal Residual Disease and Disease Prognosis After Surgery in Early Pancreatic Ductal Adenocarcinoma: A Single-center, Prospective, Observational Case Study
- ClinicalTrials.gov ID
- NCT06151691
- Acronym / sponsor ID
- PC-MRD
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Collaborators
- Shanghai Weihe Medical Laboratory Co., Ltd.
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 30 Nov 2023 (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.
This trial aims to develop a minimal residual disease (MRD) detection model for predicting recurrence of patients with stage I-II pancreatic ductal adenocarcinoma after surgery and adjuvant therapy, based on cfDNA fragmentation and methylation signal.
Detailed description
The entire study is divided into two stages. Stage one is the enrollment period. 51 subjects with pancreatic ductal adenocarcinoma in stages I-II who have not received neoadjuvant therapy and have undergone radical surgery were enrolled. Blood samples at the time point before surgical treatment (T0) were collected and fresh tissue specimens (cancerous tissue and adjacent normal tissue) were collected. Blood samples were subjected to methylation, fragment group, and CNV multi-omics testing, and tissue samples were subjected to target methylation area testing. Stage two is the follow-up period. Blood samples from the fifth week after surgery to before adjuvant therapy (T1) and blood samples from 4-8 weeks after adjuvant therapy (T2) were collected. Blood samples were subjected to methylation, fragment group, and CNV multi-omics testing with different techniques. The subjects were followed up for 1.5 years. According to progression and recurrence, the subjects were divided into progression group and non-progression group. Methylation and multi-omics prognosis models were trained and compared for their performance in residual detection and recurrence prediction.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Case-Cancer arm | – | Other: Blood collection and Pancreatic ductal adenocarcinoma minimal residual disease detection testBlood collection and Pancreatic ductal adenocarcinoma minimal residual disease detection test |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible participants will be recruited from clinic and medical centers. Participants are defined as new diagnosis cancer patients with pancreatic ductal adenocarcinoma. Demographic and cancer risk-related characteristics (eg, age, gender, smoking status, diabetes) will be collected from all enrolled subjects.
Key inclusion criteria (7 listed)
- Patients with clinically and/or pathologically diagnosis of stage I/II pancreatic ductal adenocarcinoma;
- Aged ≥ 40 years and < 75 years, both sexes;
- Patients receive radical resection with curative intent, followed by adjuvant therapy;
- Tumour size not less than 1 cm * 1 cm * 1 cm and be able to provide surgical tissue samples for molecular testing after pathological evaluation;
- Eastern Cooperative Oncology Group (ECOG) score of 0-2;
Key exclusion criteria (8 listed)
- Pregnant and lactating (by self-report);
- Any tumor history of malignancies;
- Positive cutting margins (R2);
- Received neoadjuvant therapy before surgery;
- Not be able to receive radical surgery;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood collection and Pancreatic ductal adenocarcinoma minimal residual disease detection testBlood samples of participants meet the inclusion/exclusion criteria will be collected. Pancreatic ductal adenocarcinoma minimal residual disease detection test. | Other | Case-Cancer arm |
Primary outcome
1.5-year disease-free survival
Time frame: 18 months
1.5-year disease-free survival of patients with pancreatic ductal adenocarcinoma receiving post-operative adjuvant chemotherapy.
4 secondary outcomes
Sensitivity of the multi-omics prognostic model
Time frame: 18 months
Specificity of the multi-omics prognostic model
Time frame: 18 months
Area under the receiver operating characteristic curve (AUROC) of the multi-omics prognostic model
Time frame: 18 months
Sensitivity of the multi-omics prognostic model in different subgroups
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Si Shi, M.D., Ph.D. contact
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, run by Fudan University at 1 site in China.
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 7 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 30 Nov 2023. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xian-Jun Yu, M.D., Ph.D. (+86 21 64175590, yuxianjun@fudanpci.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1.5-year disease-free survival (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Nov 2023.