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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

300 Participants
are grouped into 3 trial groups
Group A: localized gastric cancer
Group B: localized colorectal cancer
Group C: localized pancreatic cancer

Trial outcomes

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

Secondary outcomes

1

disease free survival (DFS)

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

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: