Clinical trial · Interventional
Bonds Between Circulating Tumoral ADN (ctDNA) and the Development of Peritoneal Carcinomatosis for Patients Under PIPAC
Study Evaluating the Bonds Between Circulating Tumoral ADN (ctDNA) and the Development of Peritoneal Carcinomatosis for Patients Treated With PIPAC
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Peritoneal Carcinomatosis | Peritoneal Carcinomatosis | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood sample (20 ml) and EORTC QLQC30 survey | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Blood sample (20ml) and Quality of Life Survey
- interventionNames
- Other: Blood sample (20 ml) and EORTC QLQC30 survey
Primary outcomes (4)
- measure
- ctDNA
- timeFrame
- change from inclusion at 12 weeks
- description
- ctDNA concentration change (ng/mL)
- measure
- Peritoneal Regression Grading Score (PRGS)
- timeFrame
- at inclusion
- description
- 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
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available