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

Study Overview
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Brief Summary
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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).

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

Conditions
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Peritoneal Carcinomatosis

Intervention / Treatment
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* Other: Blood sample (20 ml) and EORTC QLQC30 survey


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PIPAC, Peritoneal Carcinomatosis, Circulating tumour DNA, Quality of Life