Clinical trial NCT04766502: Bonds Between Circulating Tumoral ADN (ctDNA) and the Development of Peritoneal Carcinomatosis for Patients Under PIPAC
Official title: Study Evaluating the Bonds Between Circulating Tumoral ADN (ctDNA) and the Development of Peritoneal Carcinomatosis for Patients Treated With PIPAC
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Peritoneal Carcinomatosis
Keywords: PIPAC
Peritoneal Carcinomatosis
Circulating tumour DNA
Quality of Life
Lead sponsor: Institut de Cancérologie de Lorraine
Sponsor class: OTHER
First posted: 2021-02-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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).


Eligibility criteria: 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

Primary outcomes:
measure: ctDNA
timeFrame: change from inclusion at 12 weeks
measure: Peritoneal Regression Grading Score (PRGS)
timeFrame: at inclusion
measure: Peritoneal Regression Grading Score (PRGS)
timeFrame: an average of 6 weeks
measure: Peritoneal Regression Grading Score (PRGS)
timeFrame: an average of 12 weeks
Secondary outcomes:
measure: PIPAC discontinuation
timeFrame: an average of 6 week
measure: PIPAC discontinuation
timeFrame: an average of 12 weeks
measure: Peritoneal cancer index mesure
timeFrame: at inclusion
measure: Peritoneal cancer index mesure
timeFrame: an average of 6 week
measure: Peritoneal cancer index mesure
timeFrame: an average of 12 weeks
measure: Quality of life mesure
timeFrame: At inclusion
measure: Quality of life mesure
timeFrame: an average of 3 weeks
measure: Quality of life mesure
timeFrame: an average of 9 weeks
measure: Quality of life mesure
timeFrame: an average of 15 weeks
Other outcomes:
Locations:
city: Vandœuvre-lès-Nancy
country: France
facility: Institut de Cancérologie de Lorraine
Study officials:
affiliation: Institut de Cancérologie de Lorraine
name: Cécilia CERIBELLI, MD
role: PRINCIPAL_INVESTIGATOR
References: