Pancreatic Neuroendocrine TumorNCT05847855
Plasma cfDNA Fragmentomics for Early pNET Detection and Differential Diagnosis of Solid Pancreatic Tumors
An observational study of Pancreatic Neuroendocrine Tumor and Solid Pancreatic Neoplasms, run by Fudan University at 2 sites in China.
Trial summary
This prospective study aims to evaluate the sensitivity and specificity of an integrated model using fragmentomic profiles of plasma cell-free DNA for early detection of pancreatic neuroendocrine tumors and differential diagnosis of solid pancreatic tumors. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pancreatic Neuroendocrine Tumor, Solid Pancreatic Neoplasms
- What is being tested?
- Blood collection
- How many people
- 1,000 participants
- Where
- 2 sitesChina
- Study dates
- 27 Feb 2023to 30 Jun 2026
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population enrolled by the main center and the sub-center is uniformly divided into four groups with the same enrollment criteria for all. 1. pNET Group: Not receiving anti-tumor treatment before surgery, and were histopathologically confirmed pancreatic neuroendocrine tumors. 2. PDAC group: Patients with histopathologically confirmed pancreatic ductal adenocarcinoma (PDAC) who have not received any anti-tumor treatment before surgery. 3. SPT group: Patients with histopathologically confirmed solid pseudopapillary tumor (SPT) of the pancreas who have not received any anti-tumor treatment before surgery. 4. Healthy group: Healthy volunteers without a history of tumors and no pancreatic organic diseases.
Who may be able to join
- Age 18 and above, regardless of gender;
- Histopathological diagnosis with non-functional pancreatic neuroendocrine tumor, pancreatic ductal adenocarcinoma or solid pseudopapillary tumor;
- Not receiving any anti-tumor treatment before surgery, including chemotherapy, embolization, ablation, radiotherapy, and molecular targeted therapy;
- No obvious surgical contraindications;
- Able to comply with research plans, follow-up plans, and other protocol requirements;
- Voluntary participation and signed informed consent.
Who cannot join
- Pathological diagnosis was not pancreatic neuroendocrine tumor, pancreatic ductal adenocarcinoma or solid pseudopapillary tumor;
- Currently diagnosed with other types of tumors or any cancer history;
- Diagnosed with familial syndromes;
- Receiving anti-tumor treatment before surgery, including chemotherapy, embolization, ablation, radiotherapy, and molecular targeted therapy;
- Ongoing fever or recipient of anti-inflammation therapy within 14 days prior to study blood draw;
- Recipient of blood transfusion within 30 days prior to study blood draw;
Show all 9Show fewer
- Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant;
- Poor health condition and not suitable for blood draw;
- Any other disease/condition deemed not suitable for study enrollment by researcher.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
Doctor, 086-18019216797, zwh0105@126.com
- Recruiting
Fudan University shanghai cancer center
Shanghai, Shanghai Municipality, 200032
Shunrong Ji, MD,PhD, 13788993956
Xianjun Yu
About this study
Official title: A Prospective Study of Plasma Cell-free DNA Fragmentomics for Early Detection of Pancreatic Neuroendocrine Tumors and Differential Diagnosis of Solid Pancreatic Tumors
This prospective study aims to evaluate the sensitivity and specificity of an integrated model using fragmentomic profiles of plasma cell-free DNA for early detection of pancreatic neuroendocrine tumors and differential diagnosis of solid pancreatic tumors.
Read the detailed description
Pancreatic neuroendocrine tumors (pNETs) are insidious and difficult to diagnose early. Approximately 36.8% of pNET patients have lymph node metastasis[1], and 20% -64% of patients have liver metastasis at the time of diagnosis[2]. The prognosis of pNETs is closely related to tumor grade and the American Joint Committee on Cancer (AJCC) staging. Among patients with known pathological grades in the United States, well-differentiated NETs had the highest median overall survival (OS, 16.2 years), moderately differentiated NETs had the worse OS (8.3 years), and poorly differentiated or undifferentiated NETs had the worst OS (10 months)[3]. The 5-year overall survival rates of localized, locally advanced, and metastatic pNETs were 93%, 77%, and 27%, respectively[4]. Given that the prognosis of early-stage pNETs is significantly better than that of advanced pNETs, early detection of pNETs can provide a cure opportunity and significantly improve survival.
In the past few decades, the application of 68Ga-DOTANOC PET/CT, magnetic resonance imaging (MRI), computed tomography (CT), and endoscopic ultrasound (EUS) has improved the detection rate of pNETs. But their application is limited by high costs, lack of sufficient sensitivity or specificity, and radiation exposure. Therefore, there is an urgent need for accurate and less invasive approaches to use in clinical practice for the early detection of pNETs.
Recently, the study of cell-free DNA (cfDNA) has provided a noninvasive approach for the diagnosis of solid malignancies. cfDNAs represent extracellular DNA fragments released from cell apoptosis and necrosis into human body fluids like plasma, thus carrying the genetic and epigenetic information from the cell and tissue of origin[5]. Among them, circulating tumor DNA (ctDNA), as a part of the total cfDNA, is released into the blood by tumor cells[6]. cfDNA fragmentomics depends on whole genome sequencing, and its characteristics mainly include copy number variation (CNV), nucleosome footprint, fragment length and motif[5, 7, 8], with targets covering the entire genome level. cfDNA fragmentomics has shown excellent predictive performance in multiple studies[5, 9-11]. Therefore, this prospective study aims to evaluate the sensitivity and specificity of an integrated model using fragmentomic profiles of plasma cell-free DNA (cfDNA) for early detection of pancreatic neuroendocrine tumors.
Additionally, once a pancreatic lesion is detected, accurate discrimination between pancreatic ductal adenocarcinoma (PDAC), pNETs and solid pseudopapillary tumor (SPT) is essential. This study therefore has two co-primary objectives: (1) to develop a fragmentomic assay that flags asymptomatic individuals likely to harbor a pNET; (2) to build a differential model that distinguishes PDAC vs pNETs vs SPT in patients with confirmed solid pancreatic neoplasms."
- Being tested
- Blood collection
- Keywords
- Pancreatic neuroendocrine tumor, cell-free DNA, fragmentomics, early detection, Solid pancreatic neoplasms
- Medical subject headings
- Adenoma, Islet Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood collectionDiagnostic test
Blood collection for fragmentomic profiles of plasma cell-free DNA. The sub-center shall use the same blood collection consumables (EDTA anticoagulant vacutainer tubes) and blood collection volume (10ml) as the main center; plasma separation shall be completed within 2 hours after blood collection, and all operations shall comply with the study's unified SOP.
| Study group | Role | What they receive |
|---|---|---|
| pNETs | Patients with pancreatic neuroendocrine tumors (pNETs). The prospective cases enrolled by the sub-center shall strictly comply with the study's inclusion/exclusion criteria, consistent with the main center, and no independent adjustment of the enrollment criteria is allowed. Receives: Diagnostic Test: Blood collection | |
| Healthy | Healthy volunteers. The prospective cases enrolled by the sub-center shall strictly comply with the study's inclusion/exclusion criteria, consistent with the main center, and no independent adjustment of the enrollment criteria is allowed. Receives: Diagnostic Test: Blood collection | |
| PDAC | Patients with pancreatic ductal adenocarcinoma (PDAC) . The prospective cases enrolled by the sub-center shall strictly comply with the study's inclusion/exclusion criteria, consistent with the main center, and no independent adjustment of the enrollment criteria is allowed. Receives: Diagnostic Test: Blood collection | |
| SPT | Patients with solid pseudopapillary tumor (SPT) of pancreas. The prospective cases enrolled by the sub-center shall strictly comply with the study's inclusion/exclusion criteria, consistent with the main center, and no independent adjustment of the enrollment criteria is allowed. Receives: Diagnostic Test: Blood collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of the integrated fragmentomic model for detecting pNETs
Sensitivity and specificity of the integrated model using fragmentomic profiles of plasma cfDNA for early detection of pNETs
Measured: From date of first blood draw until first documented pNETs diagnosis, assessed up to 3 years.
Sensitivity and specificity of the model for differential diagnosis among solid pancreatic tumors
Sensitivity and specificity of the model for differential diagnosis among PDAC, pNET and SPT.
Measured: From first blood draw until histopathological diagnosis, up to 3 years
Secondary outcomes (2)
Positive predictive value and negative predictive value
Positive predictive value (PPV) and negative predictive value (NPV) of the integrated model using fragmentomic profiles of plasma cfDNA for early detection of pNETs
Measured: From date of first blood draw until first documented pNETs diagnosis, assessed up to 3 years
Accuracy of the model in predicting AJCC stage (where applicable) and tumor grade
Sensitivity and specificity of the integrated model using fragmentomic profiles of plasma cfDNA in predicting AJCC stage (where applicable) and tumor grade
Measured: From date of first blood draw until first documented histopathological diagnosis, assessed up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2023
- Study start27 Feb 2023
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Pancreatic Neuroendocrine TumorStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- West China Hospital
- Responsible party
- Principal investigator, Xian-Jun Yu, Fudan University
- Investigators
- Xianjun Yu, MD, PhD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05847855
- Sponsor's protocol ID
- CSPAC-NEN-4
- Status last verified
- Mar 2026
- First submitted
- 27 Apr 2023
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fischer L, Bergmann F, Schimmack S, Hinz U, Priess S, Muller-Stich BP, Werner J, Hackert T, Buchler MW. Outcome of surgery for pancreatic neuroendocrine neoplasms. Br J Surg. 2014 Oct;101(11):1405-12. doi: 10.1002/bjs.9603. Epub 2014 Aug 13.
PubMed 25132004Dasari A, Shen C, Halperin D, Zhao B, Zhou S, Xu Y, Shih T, Yao JC. Trends in the Incidence, Prevalence, and Survival Outcomes in Patients With Neuroendocrine Tumors in the United States. JAMA Oncol. 2017 Oct 1;3(10):1335-1342. doi: 10.1001/jamaoncol.2017.0589.
PubMed 28448665Zhang X, Wang Z, Tang W, Wang X, Liu R, Bao H, Chen X, Wei Y, Wu S, Bao H, Wu X, Shao Y, Fan J, Zhou J. Ultrasensitive and affordable assay for early detection of primary liver cancer using plasma cell-free DNA fragmentomics. Hepatology. 2022 Aug;76(2):317-329. doi: 10.1002/hep.32308. Epub 2022 Jan 26.
PubMed 34954829Fece de la Cruz F, Corcoran RB. Methylation in cell-free DNA for early cancer detection. Ann Oncol. 2018 Jun 1;29(6):1351-1353. doi: 10.1093/annonc/mdy134. No abstract available.
PubMed 29668834Mathios D, Johansen JS, Cristiano S, Medina JE, Phallen J, Larsen KR, Bruhm DC, Niknafs N, Ferreira L, Adleff V, Chiao JY, Leal A, Noe M, White JR, Arun AS, Hruban C, Annapragada AV, Jensen SO, Orntoft MW, Madsen AH, Carvalho B, de Wit M, Carey J, Dracopoli NC, Maddala T, Fang KC, Hartman AR, Forde PM, Anagnostou V, Brahmer JR, Fijneman RJA, Nielsen HJ, Meijer GA, Andersen CL, Mellemgaard A, Bojesen SE, Scharpf RB, Velculescu VE. Detection and characterization of lung cancer using cell-free DNA fragmentomes. Nat Commun. 2021 Aug 20;12(1):5060. doi: 10.1038/s41467-021-24994-w.
PubMed 34417454Snyder MW, Kircher M, Hill AJ, Daza RM, Shendure J. Cell-free DNA Comprises an In Vivo Nucleosome Footprint that Informs Its Tissues-Of-Origin. Cell. 2016 Jan 14;164(1-2):57-68. doi: 10.1016/j.cell.2015.11.050.
PubMed 26771485Guo W, Chen X, Liu R, Liang N, Ma Q, Bao H, Xu X, Wu X, Yang S, Shao Y, Tan F, Xue Q, Gao S, He J. Sensitive detection of stage I lung adenocarcinoma using plasma cell-free DNA breakpoint motif profiling. EBioMedicine. 2022 Jul;81:104131. doi: 10.1016/j.ebiom.2022.104131. Epub 2022 Jun 30.
PubMed 35780566Bao H, Wang Z, Ma X, Guo W, Zhang X, Tang W, Chen X, Wang X, Chen Y, Mo S, Liang N, Ma Q, Wu S, Xu X, Chang S, Wei Y, Zhang X, Bao H, Liu R, Yang S, Jiang Y, Wu X, Li Y, Zhang L, Tan F, Xue Q, Liu F, Cai S, Gao S, Peng J, Zhou J, Shao Y. Letter to the Editor: An ultra-sensitive assay using cell-free DNA fragmentomics for multi-cancer early detection. Mol Cancer. 2022 Jun 11;21(1):129. doi: 10.1186/s12943-022-01594-w.
PubMed 35690859Ma X, Chen Y, Tang W, Bao H, Mo S, Liu R, Wu S, Bao H, Li Y, Zhang L, Wu X, Cai S, Shao Y, Liu F, Peng J. Multi-dimensional fragmentomic assay for ultrasensitive early detection of colorectal advanced adenoma and adenocarcinoma. J Hematol Oncol. 2021 Oct 26;14(1):175. doi: 10.1186/s13045-021-01189-w.
PubMed 34702327
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Plasma Cell-free DNA Fragmentomics for Early Detection of Pancreatic Neuroendocrine Tumors and Differential Diagnosis of Solid Pancreatic Tumors
- ClinicalTrials.gov ID
- NCT05847855
- Acronym / sponsor ID
- CSPAC-NEN-4
- Keywords
- Pancreatic neuroendocrine tumor, cell-free DNA, fragmentomics, early detection, Solid pancreatic neoplasms
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Collaborators
- West China Hospital
- Study start
- 27 Feb 2023 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 8 May 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 prospective study aims to evaluate the sensitivity and specificity of an integrated model using fragmentomic profiles of plasma cell-free DNA for early detection of pancreatic neuroendocrine tumors and differential diagnosis of solid pancreatic tumors.
Detailed description
Pancreatic neuroendocrine tumors (pNETs) are insidious and difficult to diagnose early. Approximately 36.8% of pNET patients have lymph node metastasis[1], and 20% -64% of patients have liver metastasis at the time of diagnosis[2]. The prognosis of pNETs is closely related to tumor grade and the American Joint Committee on Cancer (AJCC) staging. Among patients with known pathological grades in the United States, well-differentiated NETs had the highest median overall survival (OS, 16.2 years), moderately differentiated NETs had the worse OS (8.3 years), and poorly differentiated or undifferentiated NETs had the worst OS (10 months)[3]. The 5-year overall survival rates of localized, locally advanced, and metastatic pNETs were 93%, 77%, and 27%, respectively[4]. Given that the prognosis of early-stage pNETs is significantly better than that of advanced pNETs, early detection of pNETs can provide a cure opportunity and significantly improve survival.
In the past few decades, the application of 68Ga-DOTANOC PET/CT, magnetic resonance imaging (MRI), computed tomography (CT), and endoscopic ultrasound (EUS) has improved the detection rate of pNETs. But their application is limited by high costs, lack of sufficient sensitivity or specificity, and radiation exposure. Therefore, there is an urgent need for accurate and less invasive approaches to use in clinical practice for the early detection of pNETs.
Recently, the study of cell-free DNA (cfDNA) has provided a noninvasive approach for the diagnosis of solid malignancies. cfDNAs represent extracellular DNA fragments released from cell apoptosis and necrosis into human body fluids like plasma, thus carrying the genetic and epigenetic information from the cell and tissue of origin[5]. Among them, circulating tumor DNA (ctDNA), as a part of the total cfDNA, is released into the blood by tumor cells[6]. cfDNA fragmentomics depends on whole genome sequencing, and its characteristics mainly include copy number variation (CNV), nucleosome footprint, fragment length and motif[5, 7, 8], with targets covering the entire genome level. cfDNA fragmentomics has shown excellent predictive performance in multiple studies[5, 9-11]. Therefore, this prospective study aims to evaluate the sensitivity and specificity of an integrated model using fragmentomic profiles of plasma cell-free DNA (cfDNA) for early detection of pancreatic neuroendocrine tumors.
Additionally, once a pancreatic lesion is detected, accurate discrimination between pancreatic ductal adenocarcinoma (PDAC), pNETs and solid pseudopapillary tumor (SPT) is essential. This study therefore has two co-primary objectives: (1) to develop a fragmentomic assay that flags asymptomatic individuals likely to harbor a pNET; (2) to build a differential model that distinguishes PDAC vs pNETs vs SPT in patients with confirmed solid pancreatic neoplasms."
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| pNETs | – | Diagnostic Test: Blood collectionPatients with pancreatic neuroendocrine tumors (pNETs). The prospective cases enrolled by the sub-center shall strictly comply with the study's inclusion/exclusion criteria, consistent with the main center, and no independent adjustment of the enrollment criteria is allowed. |
| Healthy | – | Diagnostic Test: Blood collectionHealthy volunteers. The prospective cases enrolled by the sub-center shall strictly comply with the study's inclusion/exclusion criteria, consistent with the main center, and no independent adjustment of the enrollment criteria is allowed. |
| PDAC | – | Diagnostic Test: Blood collectionPatients with pancreatic ductal adenocarcinoma (PDAC) . The prospective cases enrolled by the sub-center shall strictly comply with the study's inclusion/exclusion criteria, consistent with the main center, and no independent adjustment of the enrollment criteria is allowed. |
| SPT | – | Diagnostic Test: Blood collectionPatients with solid pseudopapillary tumor (SPT) of pancreas. The prospective cases enrolled by the sub-center shall strictly comply with the study's inclusion/exclusion criteria, consistent with the main center, and no independent adjustment of the enrollment criteria is allowed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population enrolled by the main center and the sub-center is uniformly divided into four groups with the same enrollment criteria for all. 1. pNET Group: Not receiving anti-tumor treatment before surgery, and were histopathologically confirmed pancreatic neuroendocrine tumors. 2. PDAC group: Patients with histopathologically confirmed pancreatic ductal adenocarcinoma (PDAC) who have not received any anti-tumor treatment before surgery. 3. SPT group: Patients with histopathologically confirmed solid pseudopapillary tumor (SPT) of the pancreas who have not received any anti-tumor treatment before surgery. 4. Healthy group: Healthy volunteers without a history of tumors and no pancreatic organic diseases.
Key inclusion criteria (6 listed)
- Age 18 and above, regardless of gender;
- Histopathological diagnosis with non-functional pancreatic neuroendocrine tumor, pancreatic ductal adenocarcinoma or solid pseudopapillary tumor;
- Not receiving any anti-tumor treatment before surgery, including chemotherapy, embolization, ablation, radiotherapy, and molecular targeted therapy;
- No obvious surgical contraindications;
- Able to comply with research plans, follow-up plans, and other protocol requirements;
Key exclusion criteria (9 listed)
- Pathological diagnosis was not pancreatic neuroendocrine tumor, pancreatic ductal adenocarcinoma or solid pseudopapillary tumor;
- Currently diagnosed with other types of tumors or any cancer history;
- Diagnosed with familial syndromes;
- Receiving anti-tumor treatment before surgery, including chemotherapy, embolization, ablation, radiotherapy, and molecular targeted therapy;
- Ongoing fever or recipient of anti-inflammation therapy within 14 days prior to study blood draw;
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 collectionBlood collection for fragmentomic profiles of plasma cell-free DNA. The sub-center shall use the same blood collection consumables (EDTA anticoagulant vacutainer tubes) and blood collection volume (10ml) as the main center; plasma separation shall be completed within 2 hours after blood collection, and all operations shall comply with the study's unified SOP. | Diagnostic test | Healthy, PDAC, SPT, pNETs |
Primary outcome
Sensitivity and specificity of the integrated fragmentomic model for detecting pNETs
Time frame: From date of first blood draw until first documented pNETs diagnosis, assessed up to 3 years.
Sensitivity and specificity of the integrated model using fragmentomic profiles of plasma cfDNA for early detection of pNETs
Sensitivity and specificity of the model for differential diagnosis among solid pancreatic tumors
Time frame: From first blood draw until histopathological diagnosis, up to 3 years
Sensitivity and specificity of the model for differential diagnosis among PDAC, pNET and SPT.
2 secondary outcomes
Positive predictive value and negative predictive value
Time frame: From date of first blood draw until first documented pNETs diagnosis, assessed up to 3 years
Accuracy of the model in predicting AJCC stage (where applicable) and tumor grade
Time frame: From date of first blood draw until first documented histopathological diagnosis, assessed up to 3 years
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 25 Mar 2026.
- Background: PubMed 25132004Fischer L, Bergmann F, Schimmack S, Hinz U, Priess S, Muller-Stich BP, Werner J, Hackert T, Buchler MW. Outcome of surgery for pancreatic neuroendocrine neoplasms. Br J Surg. 2014 Oct;101(11):1405-12. doi: 10.1002/bjs.9603. Epub 2014 Aug 13.
- Background: PubMed 28448665Dasari A, Shen C, Halperin D, Zhao B, Zhou S, Xu Y, Shih T, Yao JC. Trends in the Incidence, Prevalence, and Survival Outcomes in Patients With Neuroendocrine Tumors in the United States. JAMA Oncol. 2017 Oct 1;3(10):1335-1342. doi: 10.1001/jamaoncol.2017.0589.
- Background: PubMed 34954829Zhang X, Wang Z, Tang W, Wang X, Liu R, Bao H, Chen X, Wei Y, Wu S, Bao H, Wu X, Shao Y, Fan J, Zhou J. Ultrasensitive and affordable assay for early detection of primary liver cancer using plasma cell-free DNA fragmentomics. Hepatology. 2022 Aug;76(2):317-329. doi: 10.1002/hep.32308. Epub 2022 Jan 26.
- Background: PubMed 29668834Fece de la Cruz F, Corcoran RB. Methylation in cell-free DNA for early cancer detection. Ann Oncol. 2018 Jun 1;29(6):1351-1353. doi: 10.1093/annonc/mdy134. No abstract available.
- Background: PubMed 34417454Mathios D, Johansen JS, Cristiano S, Medina JE, Phallen J, Larsen KR, Bruhm DC, Niknafs N, Ferreira L, Adleff V, Chiao JY, Leal A, Noe M, White JR, Arun AS, Hruban C, Annapragada AV, Jensen SO, Orntoft MW, Madsen AH, Carvalho B, de Wit M, Carey J, Dracopoli NC, Maddala T, Fang KC, Hartman AR, Forde PM, Anagnostou V, Brahmer JR, Fijneman RJA, Nielsen HJ, Meijer GA, Andersen CL, Mellemgaard A, Bojesen SE, Scharpf RB, Velculescu VE. Detection and characterization of lung cancer using cell-free DNA fragmentomes. Nat Commun. 2021 Aug 20;12(1):5060. doi: 10.1038/s41467-021-24994-w.
- Background: PubMed 26771485Snyder MW, Kircher M, Hill AJ, Daza RM, Shendure J. Cell-free DNA Comprises an In Vivo Nucleosome Footprint that Informs Its Tissues-Of-Origin. Cell. 2016 Jan 14;164(1-2):57-68. doi: 10.1016/j.cell.2015.11.050.
- Background: PubMed 35780566Guo W, Chen X, Liu R, Liang N, Ma Q, Bao H, Xu X, Wu X, Yang S, Shao Y, Tan F, Xue Q, Gao S, He J. Sensitive detection of stage I lung adenocarcinoma using plasma cell-free DNA breakpoint motif profiling. EBioMedicine. 2022 Jul;81:104131. doi: 10.1016/j.ebiom.2022.104131. Epub 2022 Jun 30.
- Background: PubMed 35690859Bao H, Wang Z, Ma X, Guo W, Zhang X, Tang W, Chen X, Wang X, Chen Y, Mo S, Liang N, Ma Q, Wu S, Xu X, Chang S, Wei Y, Zhang X, Bao H, Liu R, Yang S, Jiang Y, Wu X, Li Y, Zhang L, Tan F, Xue Q, Liu F, Cai S, Gao S, Peng J, Zhou J, Shao Y. Letter to the Editor: An ultra-sensitive assay using cell-free DNA fragmentomics for multi-cancer early detection. Mol Cancer. 2022 Jun 11;21(1):129. doi: 10.1186/s12943-022-01594-w.
- Background: PubMed 34702327Ma X, Chen Y, Tang W, Bao H, Mo S, Liu R, Wu S, Bao H, Li Y, Zhang L, Wu X, Cai S, Shao Y, Liu F, Peng J. Multi-dimensional fragmentomic assay for ultrasensitive early detection of colorectal advanced adenoma and adenocarcinoma. J Hematol Oncol. 2021 Oct 26;14(1):175. doi: 10.1186/s13045-021-01189-w.
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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.
Xianjun Yu, MD, PhD principal investigator
Fudan University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Neuroendocrine Tumor and Solid Pancreatic Neoplasms, run by Fudan University at 2 sites 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 6 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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 Xianjun Yu, MD, PhD (021-64175590-88503, yuxianjun@fudanpci.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of the integrated fragmentomic model for detecting pNETs (time frame: From date of first blood draw until first documented pNETs diagnosis, assessed up to 3 years.). The study lists 2 primary outcomes in all. 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 NCT05847855, which also lists 9 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 25 Mar 2026.