Gastric Cancer (GC)PREDIPERNCT07574957
Prediction of Peritoneal Dissemination of Digestive Tumors Through the Study of Circulating Tumor DNA
An observational study of Gastric Cancer (GC) and Pancreatic Cancer, run by Assistance Publique - Hôpitaux de Paris.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer (GC), Pancreatic Cancer, Colorectal Cancer
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 1 Jun 2033
- 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
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Prédiction de la dissémination péritonéale Des Tumeurs Digestives Par étude de l'ADN Tumoral Circulant
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).
Read the detailed description
After screening, verification of inclusion and exclusion criteria, information and consent, patients will be enrolled in the study.
Several samples will be collected at different time points during patient management, in addition to samples already performed as part of routine care. No intervention or sampling will occur at a time point specifically required for research purposes. Blood and peritoneal fluid samples will always be collected concomitantly. They will then be transported to the molecular biology laboratory for initial DNA extraction. After extraction, samples will be stored at -80 °C until analysis.
The treatments offered to the patient follow standard-of-care recommendations and are not modified by participation in the study.
Three independent cohorts will be evaluated: gastric cancer, colon cancer, and pancreatic cancer.Depending on the type of cancer and the therapeutic strategy, different samples will be collected.
Systematic sampling:
Plasma: at diagnosis, at the time of surgery, in the early postoperative period, and 1 month after surgery (during the postoperative visit).
Peritoneal fluid: at the time of surgery and in the early postoperative period.
Specific sampling:
Peritoneal fluid: during pre-therapeutic exploratory laparoscopy (gastric cancer) or during diverting colostomy (obstructive colon cancer).
In total:
Gastric cancer: 3 peritoneal fluid samples and 4 blood samples.
Colon cancer: 2 peritoneal fluid samples and 3 blood samples systematically, plus 1 optional blood and peritoneal fluid sample (only in case of diverting colostomy).
Pancreatic cancer: 2 peritoneal fluid samples and 3 systematic blood samples, plus 1 optional blood sample (in case of neoadjuvant treatment).
Blood sampling:
2 EDTA tubes (molecular biology)
Peritoneal fluid sampling:
2 dry tubes (molecular biology, pathology)
For intraoperative sampling, a peritoneal washing is performed with 200 mL of 0.9% NaCl instilled into the abdominal cavity; then 50 mL are collected from the pouch of Douglas.
For the postoperative period, the sample will be collected between postoperative day 2 and day 5 directly from the drainage fluid (collected from the drain reservoir left in place at the end of surgery).
ctDNA analysis: NGS (next-generation sequencing), or high-throughput sequencing, is a molecular biology method that enables the rapid sequencing of millions of DNA molecules simultaneously and is used to identify point mutations as well as insertions, duplications, and deletions. It will be used for both plasma analysis and peritoneal fluid analysis.
- Conditions
- Gastric Cancer (GC), Pancreatic Cancer, Colorectal Cancer
- Medical subject headings
- Stomach Neoplasms, Pancreatic Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
peritoneal progression free survival (PPFS)
PPFS will be evaluated according to the circulating tumor DNA in the blood and in the peritoneal fluid
Measured: 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
Measured: Time from the start of treatment until recurrence assessed up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Jun 2033 (estimated)
- Study completion1 Jun 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Cancer (GC)Studies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07574957
- Sponsor's protocol ID
- APHP251031
- Acronym
- PREDIPER
- Status last verified
- May 2026
- First submitted
- 10 Mar 2026
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prédiction de la dissémination péritonéale Des Tumeurs Digestives Par étude de l'ADN Tumoral Circulant
- ClinicalTrials.gov ID
- NCT07574957
- Acronym / sponsor ID
- PREDIPER / APHP251031
- Conditions
- Gastric Cancer (GC), Pancreatic Cancer, Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Jun 2033 (estimated)
- Study completion
- 1 Jun 2033 (estimated)
- First posted
- 8 May 2026 (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.
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).
Detailed description
After screening, verification of inclusion and exclusion criteria, information and consent, patients will be enrolled in the study.
Several samples will be collected at different time points during patient management, in addition to samples already performed as part of routine care. No intervention or sampling will occur at a time point specifically required for research purposes. Blood and peritoneal fluid samples will always be collected concomitantly. They will then be transported to the molecular biology laboratory for initial DNA extraction. After extraction, samples will be stored at -80 °C until analysis.
The treatments offered to the patient follow standard-of-care recommendations and are not modified by participation in the study.
Three independent cohorts will be evaluated: gastric cancer, colon cancer, and pancreatic cancer.Depending on the type of cancer and the therapeutic strategy, different samples will be collected.
Systematic sampling:
Plasma: at diagnosis, at the time of surgery, in the early postoperative period, and 1 month after surgery (during the postoperative visit).
Peritoneal fluid: at the time of surgery and in the early postoperative period.
Specific sampling:
Peritoneal fluid: during pre-therapeutic exploratory laparoscopy (gastric cancer) or during diverting colostomy (obstructive colon cancer).
In total:
Gastric cancer: 3 peritoneal fluid samples and 4 blood samples.
Colon cancer: 2 peritoneal fluid samples and 3 blood samples systematically, plus 1 optional blood and peritoneal fluid sample (only in case of diverting colostomy).
Pancreatic cancer: 2 peritoneal fluid samples and 3 systematic blood samples, plus 1 optional blood sample (in case of neoadjuvant treatment).
Blood sampling:
2 EDTA tubes (molecular biology)
Peritoneal fluid sampling:
2 dry tubes (molecular biology, pathology)
For intraoperative sampling, a peritoneal washing is performed with 200 mL of 0.9% NaCl instilled into the abdominal cavity; then 50 mL are collected from the pouch of Douglas.
For the postoperative period, the sample will be collected between postoperative day 2 and day 5 directly from the drainage fluid (collected from the drain reservoir left in place at the end of surgery).
ctDNA analysis: NGS (next-generation sequencing), or high-throughput sequencing, is a molecular biology method that enables the rapid sequencing of millions of DNA molecules simultaneously and is used to identify point mutations as well as insertions, duplications, and deletions. It will be used for both plasma analysis and peritoneal fluid analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
peritoneal progression free survival (PPFS)
Time frame: Time from the start of treatment until peritoneal recurrence assessed up to 36 months
PPFS will be evaluated according to the circulating tumor DNA in the blood and in the peritoneal fluid
1 secondary outcome
disease free survival (DFS)
Time frame: Time from the start of treatment until recurrence assessed up to 36 months
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 8 May 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer (GC) and Pancreatic Cancer, run by Assistance Publique - Hôpitaux de Paris.
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 5 inclusion and 7 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: opening soon, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
peritoneal progression free survival (PPFS) (time frame: Time from the start of treatment until peritoneal recurrence assessed up to 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 May 2026.