Bonds Between Circulating Tumoral ADN (ctDNA) and the Development of Peritoneal Carcinomatosis for Patients Under PIPAC

NCT04766502 | Completed

• 1 other identifier: 2021-A00645-36
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

PIPADN is a pilot monocentric, study with a total duration of 42 months. The purpose of this study is to describe the variation of plasma ctDNA concentration between the 1st and the 3rd PIPAC session in patients with peritoneal carcinomatosis. The improvement of life quality with this type of treatment will also be evaluated though the EORTC QLQ-C30 survey. Each patient will have three PIPAC sessions spaced 6 to 8 weeks apart. Two blood samples will be taken during the first 3 PIPAC sessions, one the day before each procedure and a second one 24 hours afterwards. The EORTC QLQ 30 survey will be completed by patients during the pre-operative consultation and at each post-operative consultation (about 3 weeks after PIPAC sessions).

Conditions

Peritoneal Carcinomatosis

Keywords

PIPAC; Peritoneal Carcinomatosis; Circulating tumour DNA; Quality of Life

Outcome Measures

Primary Outcomes (4)

• ctDNA

  ctDNA concentration change (ng/mL)

  change from inclusion at 12 weeks

• Peritoneal Regression Grading Score (PRGS)

  Results of each PIPAC will be evaluated using PRGS. PRGS (Peritoneal Regression Grading Score), going from 1 : no tumor cells, to 4 :solid growth in tumor cells

  at inclusion

• Peritoneal Regression Grading Score (PRGS)

  Results of each PIPAC will be evaluated using PRGS. PRGS : (Peritoneal Regression Grading Score), going from 1 : no tumor cells, to 4 :solid growth in tumor cells

  an average of 6 weeks

• Peritoneal Regression Grading Score (PRGS)

  Results of each PIPAC will be evaluated using PRGS. PRGS (Peritoneal Regression Grading Score), going from 1 : no tumor cells, to 4 :solid growth in tumor cells

  an average of 12 weeks

Secondary Outcomes (9)

• PIPAC discontinuation

  an average of 6 week

• PIPAC discontinuation

  an average of 12 weeks

• Peritoneal cancer index mesure

  at inclusion

• Peritoneal cancer index mesure

  an average of 6 week

• Peritoneal cancer index mesure

  an average of 12 weeks

Study Arms (1)

Blood sample (20ml) and Quality of Life Survey

EXPERIMENTAL

Other: Blood sample (20 ml) and EORTC QLQC30 survey

Interventions

Blood sample (20 ml) and EORTC QLQC30 survey OTHER

Blood sample (20ml) will be taken before and 24h after PIPAC procedure EORTC QLQC30 during pre operative consultation and at each post operative consultations

Blood sample (20ml) and Quality of Life Survey

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years old
• WHO 0 to 2
• Patient with cancer in the form of peritoneal carcinosmatois not eligible for cytoreduction surgery
• A histological diagnosis of the primary tumor or peritoneal carcinomatosis is essential.
• Patient with an indication for PIPAC for any reason (whether as part of a clinical research protocol or not). Patients with prior treatment with PIPAC are eligible.
• Patients with abdominal metastases or a single metastasis regardless of location (oligometastasis).
• For patients of childbearing age need for an effective method of contraception
• Informing patients and obtaining informed consent, dated and signed.
• Patient affiliated with a social security scheme

You may not qualify if:

• Age \< 18 years old
• WHO \> 3
• Patient who may benefit from cytoreduction surgery
• Patient with a contraindication to PIPAC
• Extra peritoneal disease with the exception of oligometastatic disease
• Persons deprived of liberty or under guardianship (including curatorship)
• Impossibility to undergo the medical follow-up of the trial for social, geographical or psychological reasons.
• For patients of childbearing age without an effective method of contraception
• Woman who is pregnant, likely to be pregnant, or breastfeeding

Sponsors & Collaborators

• Institut de Cancérologie de Lorraine: lead

Study Sites (1)

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, France

Location

MeSH Terms

Conditions

Peritoneal Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Abdominal Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Peritoneal Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Cécilia CERIBELLI, MD

  Institut de Cancérologie de Lorraine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2021
• First Posted: February 23, 2021
• Study Start: January 11, 2022
• Primary Completion: December 10, 2024
• Study Completion: January 7, 2025
• Last Updated: July 24, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)