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Completed

NCT Number: NCT04766502

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood sample (20 ml) and EORTC QLQC30 survey

Other

Blood sample (20ml) will be taken before and 24h after PIPAC procedure

EORTC QLQC30 during pre operative consultation and at each post operative consultations

Primary outcomes

  1. ctDNA

    Time frame: change from inclusion at 12 weeks

    ctDNA concentration change (ng/mL)

  2. Peritoneal Regression Grading Score (PRGS)

    Time frame: at inclusion

    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

  3. Peritoneal Regression Grading Score (PRGS)

    Time frame: an average of 6 weeks

    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

  4. Peritoneal Regression Grading Score (PRGS)

    Time frame: an average of 12 weeks

    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

Secondary outcomes

  1. PIPAC discontinuation

    Time frame: an average of 6 week

    The reason (ei : progression, deterioration of the patient's general condition) of PIPAC discontinuation for patient who have had less than 3 PIPAC sessions

  2. PIPAC discontinuation

    Time frame: an average of 12 weeks

    The reason (ei : progression, deterioration of the patient's general condition) of PIPAC discontinuation for patient who have had less than 3 PIPAC sessions

  3. Peritoneal cancer index mesure

    Time frame: at inclusion

    Evaluation of disease extent

  4. Peritoneal cancer index mesure

    Time frame: an average of 6 week

    Evaluation of disease extent

  5. Peritoneal cancer index mesure

    Time frame: an average of 12 weeks

    Evaluation of disease extent

  6. Quality of life mesure

    Time frame: At inclusion

    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

  7. Quality of life mesure

    Time frame: an average of 3 weeks

    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

  8. Quality of life mesure

    Time frame: an average of 9 weeks

    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

  9. Quality of life mesure

    Time frame: an average of 15 weeks

    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

Sponsors and collaborators

Lead sponsor

Institut de Cancérologie de Lorraine

Other

Registry information

Official study title

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

Acronym: PIPADN

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Feb 23, 2021
Registry last updated
Jul 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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