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

Peritoneal Carcinomatosis Clinical Trial

— PIPADN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04766502
• Other study ID #: 2021-A00645-36
• Status: Recruiting
• Phase: N/A
• Start date: January 11, 2022
• Est. completion date: January 2024

Study information

• Verified date: July 2023
• Source: Institut de Cancérologie de Lorraine
• Contact: Jean Louis MERLIN, PU PH
• Phone: 03 83 65 60 62
• Email: jl.merlin[@]nancy.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: January 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Peritoneal Carcinomatosis
• Peritoneal Neoplasms

Intervention

Other:
• Blood sample (20 ml) and EORTC QLQC30 survey
Blood sample (20ml) will be taken before and 24h after PIPAC procedure EORTC QLQC30 during pre operative consultation and at each post operative consultations

Locations

Country	Name	City	State
France	Institut de Cancérologie de Lorraine	Vandœuvre-lès-Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Institut de Cancérologie de Lorraine

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ctDNA	ctDNA concentration change (ng/mL)	change from inclusion at 12 weeks
Primary	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	at inclusion
Primary	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	an average of 6 weeks
Primary	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	an average of 12 weeks
Secondary	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	an average of 6 week
Secondary	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	an average of 12 weeks
Secondary	Peritoneal cancer index mesure	Evaluation of disease extent	at inclusion
Secondary	Peritoneal cancer index mesure	Evaluation of disease extent	an average of 6 week
Secondary	Peritoneal cancer index mesure	Evaluation of disease extent	an average of 12 weeks
Secondary	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	At inclusion
Secondary	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	an average of 3 weeks
Secondary	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	an average of 9 weeks
Secondary	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	an average of 15 weeks