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

Institut de Cancérologie de Lorraine

Status

Completed

Conditions

Peritoneal Carcinomatosis

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT04766502

2021-A00645-36

Details and patient eligibility

About

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).

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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