Prediction of Peritoneal Dissemination of Digestive Tumors Through the Study of Circulating Tumor DNA

NCT07574957 | Not Yet Recruiting

• 1 other identifier: APHP251031
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

The peritoneum is a relatively frequent metastatic site in digestive tumors (colon, stomach, pancreas) and is characterized by a poorer prognosis compared with other metastatic sites such as the lung or liver. Its dissemination pathway is complex and most often involves crossing the hemato-peritoneal barrier. This type of metastasis is difficult to visualize on imaging at an early stage, and surgical exploration may be required. In gastric cancer in particular, exploratory laparoscopy is part of the initial staging work-up for locally advanced tumors to assess the presence or absence of peritoneal metastases. It is therefore important to develop new, less invasive detection or prediction methods. Circulating tumor DNA (ctDNA) is a promising non-invasive blood biomarker that can assist clinicians as a prognostic/predictive biomarker and/or a tool for monitoring response to anti-tumor therapies. This marker is most often assessed in plasma, but recent data suggest that tumor DNA may also be detected in other biological fluids such as peritoneal fluid. A preliminary study conducted by our team showed the ability to detect tumor DNA in peritoneal fluid from patients with peritoneal carcinomatosis of various origins, with a sensitivity of 75%. In gastric cancer, a recent meta-analysis demonstrated an increased risk of peritoneal metastases when peritoneal tumor DNA was positive (RR 13.81 \[95% CI, 8.11-23.53\]), as well as a reduction in 3-year recurrence-free survival (RR 5.37 \[95% CI, 1.39-20.74\]) and overall survival (HR 4.13 \[95% CI, 1.51-11.32\]). The objective of this cohort is to evaluate the prognostic impact of circulating tumor DNA (ctDNA) in plasma and/or peritoneal fluid on the risk of developing peritoneal metastases. The primary endpoint is: Peritoneal recurrence rate according to tumor DNA positivity status (positive vs negative).

Conditions

Gastric Cancer (GC); Pancreatic Cancer; Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• peritoneal progression free survival (PPFS)

  PPFS will be evaluated according to the circulating tumor DNA in the blood and in the peritoneal fluid

  Time from the start of treatment until peritoneal recurrence assessed up to 36 months

Secondary Outcomes (1)

• disease free survival (DFS)

  Time from the start of treatment until recurrence assessed up to 36 months

Study Arms (3)

localized gastric cancer

resectable tumor receiving neoajuvant chemotherapy and curative gastrectomy

localized colorectal cancer

resectable tumor receiving neoajuvant chemotherapy or not and curative colectomy

localized pancreatic cancer

resectable tumor receiving neoajuvant chemotherapy or not and curative pancreatectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients treated for a histologically proven, localized adenocarcinoma of gastric or pancreatic or colorectal, will be enrolled in this prospective cohort study after receiving and signed a specific consent information form.

You may qualify if:

• Age \> 18 years
• Signed non-opposition form
• For gastric cancer: histologically confirmed gastric adenocarcinoma \>T2 and/or N+; for colon cancer: histologically confirmed colonic adenocarcinoma \>T2; for pancreatic cancer: histologically confirmed pancreatic adenocarcinoma \>T2
• No metastases on the initial staging work-up
• No contraindication to curative-intent surgical treatment

You may not qualify if:

• Primary tumor metastatic at diagnosis
• Presence of ascites or distant metastases
• Synchronous cancer or prior history of cancer within the past 5 years
• Contraindication to curative surgical treatment
• Any patient unable to comply with the study's medical follow-up for geographic, social, or psychological reasons
• Patients under legal guardianship/protection, or unable to read, understand, and sign the information notice and consent form
• Patients not affiliated with the social security system

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Biospecimen

Retention: SAMPLES WITH DNA

blood samples and peritoneal fluid samples circulating tumor DNA

MeSH Terms

Conditions

Stomach Neoplasms; Pancreatic Neoplasms; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2026
• First Posted: May 8, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2033
• Study Completion (Estimated): June 1, 2033
• Last Updated: May 8, 2026

Record last verified: 2026-05