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

Study Evaluating the Bonds Between Circulating Tumoral ADN (ctDNA) and the Development of Peritoneal Carcinomatosis for Patients Treated With PIPAC

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).

Study Overview

• Status: Recruiting
• Conditions: Peritoneal Carcinomatosis
• Intervention / Treatment: Other: Blood sample (20 ml) and EORTC QLQC30 survey

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jean Louis MERLIN, PU PH; Phone Number: 0033 03 83 65 60 62; Email: jl.merlin@nancy.unicancer.fr
• Study Contact Backup: Name: Marie-Aude HERMAN; Phone Number: 0033 03 83 53 86 68; Email: m.herman@nancy.unicancer.fr

Study Locations

• France
  • Vandœuvre-lès-Nancy, France
    • Recruiting
    • Institut de cancérologie de Lorraine
    • Contact: Cécilia CERIBELLI, MD; Phone Number: 0033 03 83 59 84 51; Email: c.ceribelli@nancy.unicancer.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Blood sample (20ml) and Quality of Life Survey	Other: Blood sample (20 ml) and EORTC QLQC30 survey; Blood sample (20ml) will be taken before and 24h after PIPAC procedure EORTC QLQC30 during pre operative consultation and at each post operative consultations

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
PIPAC discontinuation	The reason (ei : progression, deterioration of the patient's general condition) of PIPAC discontinuation for patient who have had less than 3 PIPAC sessions	an average of 6 week
PIPAC discontinuation	The reason (ei : progression, deterioration of the patient's general condition) of PIPAC discontinuation for patient who have had less than 3 PIPAC sessions	an average of 12 weeks
Peritoneal cancer index mesure	Evaluation of disease extent	at inclusion
Peritoneal cancer index mesure	Evaluation of disease extent	an average of 6 week
Peritoneal cancer index mesure	Evaluation of disease extent	an average of 12 weeks
Quality of life mesure	Quality of life will be mesured by EORTC Quality of Life C30 survey. EORTC : European Organization for Research and Treatment of Cancer. Measured from 0 to 35, 0 meaning minimal mictionnal discomfort, 35 meaning maximal mictionnal discomfort	At inclusion
Quality of life mesure	Quality of life will be mesured by EORTC Quality of Life C30 survey. EORTC : European Organization for Research and Treatment of Cancer. Measured from 0 to 35, 0 meaning minimal mictionnal discomfort, 35 meaning maximal mictionnal discomfort	an average of 3 weeks
Quality of life mesure	Quality of life will be mesured by EORTC Quality of Life C30 survey. EORTC : European Organization for Research and Treatment of Cancer. Measured from 0 to 35, 0 meaning minimal mictionnal discomfort, 35 meaning maximal mictionnal discomfort	an average of 9 weeks
Quality of life mesure	Quality of life will be mesured by EORTC Quality of Life C30 survey. EORTC : European Organization for Research and Treatment of Cancer. Measured from 0 to 35, 0 meaning minimal mictionnal discomfort, 35 meaning maximal mictionnal discomfort	an average of 15 weeks

Collaborators and Investigators

• Sponsor: Institut de Cancérologie de Lorraine
• Investigators: Principal Investigator: Cécilia CERIBELLI, MD, Institut de cancérologie de Lorraine

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2022
• Primary Completion (Estimated): January 1, 2024
• Study Completion (Estimated): January 1, 2024

Study Registration Dates

• First Submitted: February 9, 2021
• First Submitted That Met QC Criteria: February 22, 2021
• First Posted (Actual): February 23, 2021

Study Record Updates

• Last Update Posted (Actual): July 28, 2023
• Last Update Submitted That Met QC Criteria: July 27, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Quality of Life; Peritoneal Carcinomatosis; PIPAC; Circulating tumour DNA
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Peritoneal Diseases; Digestive System Neoplasms; Abdominal Neoplasms; Carcinoma; Peritoneal Neoplasms
• Other Study ID Numbers: 2021-A00645-36

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No