Peritoneal CarcinomatosisPIPADNNCT04766502
Bonds Between Circulating Tumoral ADN (ctDNA) and the Development of Peritoneal Carcinomatosis for Patients Under PIPAC
A study testing Blood sample (20 ml) and EORTC QLQC30 survey in people with Peritoneal Carcinomatosis, run by Institut de Cancérologie de Lorraine at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peritoneal Carcinomatosis
- What is being tested?
- Blood sample (20 ml) and EORTC QLQC30 survey
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 11 Jan 2022to 7 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Show all 9Show fewer
- 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
Who cannot join
- 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)
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study Evaluating the Bonds Between Circulating Tumoral ADN (ctDNA) and the Development of Peritoneal Carcinomatosis for Patients Treated With 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.
Read more
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
- Peritoneal Carcinomatosis
- Being tested
- Blood sample (20 ml) and EORTC QLQC30 survey
- Keywords
- PIPAC, Peritoneal Carcinomatosis, Circulating tumour DNA, Quality of Life
- Medical subject headings
- Peritoneal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sample (20 ml) and EORTC QLQC30 surveyOther
Blood sample (20ml) will be taken before and 24h after PIPAC procedure
EORTC QLQC30 during pre operative consultation and at each post operative consultations
| Study group | Role | What they receive |
|---|---|---|
| Blood sample (20ml) and Quality of Life Survey | Experimental | Not described Receives: Other: Blood sample (20 ml) and EORTC QLQC30 survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
ctDNA
ctDNA concentration change (ng/mL)
Measured: change from inclusion at 12 weeks
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
Measured: at inclusion
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
Measured: an average of 6 weeks
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
Measured: an average of 12 weeks
Secondary outcomes (9)
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
Measured: an average of 6 week
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
Measured: an average of 12 weeks
Peritoneal cancer index mesure
Evaluation of disease extent
Measured: at inclusion
Peritoneal cancer index mesure
Evaluation of disease extent
Measured: an average of 6 week
Peritoneal cancer index mesure
Evaluation of disease extent
Measured: an average of 12 weeks
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
Measured: At inclusion
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
Measured: an average of 3 weeks
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
Measured: an average of 9 weeks
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
Measured: an average of 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study start11 Jan 2022
- Primary completion10 Dec 2024
- Study completion7 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritoneal CarcinomatosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Cancérologie de Lorraine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cécilia CERIBELLI, MD, Principal investigator, Institut de Cancérologie de Lorraine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04766502
- Sponsor's protocol ID
- 2021-A00645-36
- Acronym
- PIPADN
- Status last verified
- Dec 2024
- First submitted
- 9 Feb 2021
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Evaluating the Bonds Between Circulating Tumoral ADN (ctDNA) and the Development of Peritoneal Carcinomatosis for Patients Treated With PIPAC
- ClinicalTrials.gov ID
- NCT04766502
- Acronym / sponsor ID
- PIPADN / 2021-A00645-36
- Conditions
- Peritoneal Carcinomatosis
- Keywords
- PIPAC, Peritoneal Carcinomatosis, Circulating tumour DNA, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Institut de Cancérologie de LorraineUniversity, hospital or other
- Study start
- 11 Jan 2022 (actual)
- Primary completion
- 10 Dec 2024 (actual)
- Study completion
- 7 Jan 2025 (actual)
- First posted
- 23 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blood sample (20ml) and Quality of Life Survey | Experimental | Other: Blood sample (20 ml) and EORTC QLQC30 survey |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sample (20 ml) and EORTC QLQC30 surveyBlood sample (20ml) will be taken before and 24h after PIPAC procedure EORTC QLQC30 during pre operative consultation and at each post operative consultations | Other | Blood sample (20ml) and Quality of Life Survey |
Primary outcome
ctDNA
Time frame: change from inclusion at 12 weeks
ctDNA concentration change (ng/mL)
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
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
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
9 secondary outcomes
PIPAC discontinuation
Time frame: an average of 6 week
PIPAC discontinuation
Time frame: an average of 12 weeks
Peritoneal cancer index mesure
Time frame: at inclusion
Peritoneal cancer index mesure
Time frame: an average of 6 week
Peritoneal cancer index mesure
Time frame: an average of 12 weeks
Quality of life mesure
Time frame: At inclusion
Quality of life mesure
Time frame: an average of 3 weeks
Quality of life mesure
Time frame: an average of 9 weeks
Quality of life mesure
Time frame: an average of 15 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
- Individual participant dataSharing planned: No
Related trials for Peritoneal Carcinomatosis
RecruitingPhase 1
Individual Response to Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Treatment of Peritoneal Carcinomatosis From Peritoneal Mesothelioma or Atypical Mesothelial Proliferation or From Ovarian, Colorectal, or Appendiceal Histologies
Peritoneal Mesothelioma, Peritoneal Carcinomatosis
RecruitingPhase 2
Combined Systemic and Intraperitoneal Chemotherapy for Synchronous Gastric and/or Gastroesophageal Peritoneal Carcinomatosis
Synchronous Gastric Peritoneal Carcinomatosis, Gastroesophageal Peritoneal Carcinomatosis
Active, not recruitingPhase 1
Determining the Biodistribution of an Imaging Tracer (68Ga-FAPi-46) in Patients With Solid Tumors or Hematologic Cancers
Anal Carcinoma, Bladder Carcinoma
RecruitingPhase 1
A Study of Mesothelin-Targeted CAR T-Cell Therapy in People With Esophagogastric Cancer or Malignant Peritoneal Mesothelioma
Mesothelin Positive, Mesothelin-Expressing Tumors
Active, not recruitingPhase 1
Paclitaxel for the Treatment of Gastric or Gastroesophageal Cancer
Clinical Stage IV Gastric Cancer AJCC v8, Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cécilia CERIBELLI, MD principal investigator
Institut de Cancérologie de Lorraine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sample (20 ml) and EORTC QLQC30 survey in people with Peritoneal Carcinomatosis, run by Institut de Cancérologie de Lorraine at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ctDNA (time frame: change from inclusion at 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2025.