NCT07574957Not yet recruiting
Prediction of Peritoneal Dissemination of Digestive Tumors Through the Study of Circulating Tumor DNA
Prédiction de la dissémination péritonéale Des Tumeurs Digestives Par étude de l'ADN Tumoral Circulant
Source: ClinicalTrials.gov · Last updated 8 May 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 300 (estimated)
- First submitted
- 10 Mar 2026
- Start date
- 1 Jun 2026
- Primary completion date
- 1 Jun 2033
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- NCT number
- NCT07574957
What you commit to
- Study type: Observational
- Planned participants: 300
- From 1 Jun 2026 to the primary completion date, 1 Jun 2033
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Contraindication to curative surgical treatment
Other illness
- Synchronous cancer or prior history of cancer within the past 5 years
Other
- Primary tumor metastatic at diagnosis
- Presence of ascites or distant metastases
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.