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

Primary Purpose

Peritoneal Carcinomatosis

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood sample (20 ml) and EORTC QLQC30 survey
Sponsored by
Institut de Cancérologie de Lorraine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Peritoneal Carcinomatosis focused on measuring PIPAC, Peritoneal Carcinomatosis, Circulating tumour DNA, Quality of Life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Institut de Cancérologie de LorraineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Blood sample (20ml) and Quality of Life Survey

Arm Description

Outcomes

Primary Outcome Measures

ctDNA
ctDNA concentration change (ng/mL)
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
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
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

Secondary Outcome Measures

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
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
Peritoneal cancer index mesure
Evaluation of disease extent
Peritoneal cancer index mesure
Evaluation of disease extent
Peritoneal cancer index mesure
Evaluation of disease extent
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
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
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
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

Full Information

First Posted
February 9, 2021
Last Updated
July 27, 2023
Sponsor
Institut de Cancérologie de Lorraine
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1. Study Identification

Unique Protocol Identification Number
NCT04766502
Brief Title
Bonds Between Circulating Tumoral ADN (ctDNA) and the Development of Peritoneal Carcinomatosis for Patients Under PIPAC
Acronym
PIPADN
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 11, 2022 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut de Cancérologie de Lorraine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peritoneal Carcinomatosis
Keywords
PIPAC, Peritoneal Carcinomatosis, Circulating tumour DNA, Quality of Life

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Blood sample (20ml) and Quality of Life Survey
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Blood sample (20 ml) and EORTC QLQC30 survey
Intervention Description
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 Outcome Measure Information:
Title
ctDNA
Description
ctDNA concentration change (ng/mL)
Time Frame
change from inclusion at 12 weeks
Title
Peritoneal Regression Grading Score (PRGS)
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
Time Frame
at inclusion
Title
Peritoneal Regression Grading Score (PRGS)
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
Time Frame
an average of 6 weeks
Title
Peritoneal Regression Grading Score (PRGS)
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
Time Frame
an average of 12 weeks
Secondary Outcome Measure Information:
Title
PIPAC discontinuation
Description
The reason (ei : progression, deterioration of the patient's general condition) of PIPAC discontinuation for patient who have had less than 3 PIPAC sessions
Time Frame
an average of 6 week
Title
PIPAC discontinuation
Description
The reason (ei : progression, deterioration of the patient's general condition) of PIPAC discontinuation for patient who have had less than 3 PIPAC sessions
Time Frame
an average of 12 weeks
Title
Peritoneal cancer index mesure
Description
Evaluation of disease extent
Time Frame
at inclusion
Title
Peritoneal cancer index mesure
Description
Evaluation of disease extent
Time Frame
an average of 6 week
Title
Peritoneal cancer index mesure
Description
Evaluation of disease extent
Time Frame
an average of 12 weeks
Title
Quality of life mesure
Description
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
Time Frame
At inclusion
Title
Quality of life mesure
Description
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
Time Frame
an average of 3 weeks
Title
Quality of life mesure
Description
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
Time Frame
an average of 9 weeks
Title
Quality of life mesure
Description
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
Time Frame
an average of 15 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean Louis MERLIN, PU PH
Phone
03 83 65 60 62
Ext
0033
Email
jl.merlin@nancy.unicancer.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Marie-Aude HERMAN
Phone
03 83 53 86 68
Ext
0033
Email
m.herman@nancy.unicancer.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cécilia CERIBELLI, MD
Organizational Affiliation
Institut de Cancérologie de Lorraine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut de Cancérologie de Lorraine
City
Vandœuvre-lès-Nancy
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cécilia CERIBELLI, MD
Phone
03 83 59 84 51
Ext
0033
Email
c.ceribelli@nancy.unicancer.fr

12. IPD Sharing Statement

Learn more about this trial

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

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