Early detection of pancreatic neuroendocrine tumors using blood tests

A Prospective Study of Plasma Cell-free DNA Fragmentomics for Early Detection of Pancreatic Neuroendocrine Tumors and Differential Diagnosis of Solid Pancreatic Tumors

This study is testing a new blood test to see if it can help find pancreatic neuroendocrine tumors earlier than current methods in adults who have not yet received treatment.

Quick facts

• Study type: Observational
• Enrollment: 1000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Fudan University (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 2 sites (Shanghai, Shanghai Municipality and 1 other locations)
• Trial ID: NCT05847855 on ClinicalTrials.gov

What this trial studies

This observational study evaluates the effectiveness of a multi-dimensional fragmentomic assay that analyzes plasma cell-free DNA to detect pancreatic neuroendocrine tumors (pNETs) at an early stage. Given the challenges in diagnosing pNETs early, the study aims to assess the sensitivity and specificity of this non-invasive approach compared to traditional imaging methods. Participants will be adults with a histopathological diagnosis of non-functional pNETs who have not undergone any anti-tumor treatments prior to surgery. Blood samples will be collected to analyze cfDNA fragmentomic profiles, which may provide insights into early tumor detection.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a histopathological diagnosis of non-functional pancreatic neuroendocrine tumors who have not received prior anti-tumor treatments.

Not a fit: Patients with other types of tumors, a history of cancer, or those currently undergoing anti-tumor treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to earlier diagnosis of pancreatic neuroendocrine tumors, improving treatment outcomes and survival rates.

How similar studies have performed: While there have been advancements in imaging techniques for pNET detection, the use of cfDNA fragmentomics for early detection is a novel approach that has not been extensively tested in similar studies.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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;
* 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.

Where this trial is running

Shanghai, Shanghai Municipality and 1 other locations

• Fudan University shanghai cancer center — Shanghai, Shanghai Municipality, China (Recruiting)
• West China Hospital, Sichuan University — Chengdu, Sichuan, China (Recruiting)

Study contacts

• Principal investigator: Xianjun Yu, MD, PhD — Fudan University
• Study coordinator: Xianjun Yu, MD, PhD

Conditions Pancreatic Neuroendocrine Tumor; Solid Pancreatic Neoplasms; Pancreatic neuroendocrine tumor; cell-free DNA; fragmentomics; early detection; Solid pancreatic neoplasms