Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-26 @ 2:30 AM
Study NCT ID:
NCT04766502
Status:
COMPLETED
Last Update Posted:
2025-07-24
First Post:
2021-02-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bonds Between Circulating Tumoral ADN (ctDNA) and the Development of Peritoneal Carcinomatosis for Patients Under PIPAC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010534', 'term': 'Peritoneal Neoplasms'}], 'ancestors': [{'id': 'D000008', 'term': 'Abdominal Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010532', 'term': 'Peritoneal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-01-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-21', 'studyFirstSubmitDate': '2021-02-09', 'studyFirstSubmitQcDate': '2021-02-22', 'lastUpdatePostDateStruct': {'date': '2025-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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': 'Peritoneal Regression Grading Score (PRGS)', 'timeFrame': 'an average of 6 weeks', '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': 'Peritoneal Regression Grading Score (PRGS)', 'timeFrame': 'an average of 12 weeks', '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'}], 'secondaryOutcomes': [{'measure': 'PIPAC discontinuation', 'timeFrame': 'an average of 6 week', '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"}, {'measure': 'PIPAC discontinuation', 'timeFrame': 'an average of 12 weeks', '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"}, {'measure': 'Peritoneal cancer index mesure', 'timeFrame': 'at inclusion', 'description': 'Evaluation of disease extent'}, {'measure': 'Peritoneal cancer index mesure', 'timeFrame': 'an average of 6 week', 'description': 'Evaluation of disease extent'}, {'measure': 'Peritoneal cancer index mesure', 'timeFrame': 'an average of 12 weeks', 'description': 'Evaluation of disease extent'}, {'measure': 'Quality of life mesure', 'timeFrame': 'At inclusion', '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'}, {'measure': 'Quality of life mesure', 'timeFrame': 'an average of 3 weeks', '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'}, {'measure': 'Quality of life mesure', 'timeFrame': 'an average of 9 weeks', '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'}, {'measure': 'Quality of life mesure', 'timeFrame': 'an average of 15 weeks', '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'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PIPAC', 'Peritoneal Carcinomatosis', 'Circulating tumour DNA', 'Quality of Life'], 'conditions': ['Peritoneal Carcinomatosis']}, 'descriptionModule': {'briefSummary': '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.\n\nThe improvement of life quality with this type of treatment will also be evaluated though the EORTC QLQ-C30 survey.\n\nEach 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.\n\nThe 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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years old\n* WHO 0 to 2\n* Patient with cancer in the form of peritoneal carcinosmatois not eligible for cytoreduction surgery\n* A histological diagnosis of the primary tumor or peritoneal carcinomatosis is essential.\n* 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.\n* Patients with abdominal metastases or a single metastasis regardless of location (oligometastasis).\n* For patients of childbearing age need for an effective method of contraception\n* Informing patients and obtaining informed consent, dated and signed.\n* Patient affiliated with a social security scheme\n\nExclusion Criteria:\n\n* Age \\< 18 years old\n* WHO \\> 3\n* Patient who may benefit from cytoreduction surgery\n* Patient with a contraindication to PIPAC\n* Extra peritoneal disease with the exception of oligometastatic disease\n* Persons deprived of liberty or under guardianship (including curatorship)\n* Impossibility to undergo the medical follow-up of the trial for social, geographical or psychological reasons.\n* For patients of childbearing age without an effective method of contraception\n* Woman who is pregnant, likely to be pregnant, or breastfeeding'}, 'identificationModule': {'nctId': 'NCT04766502', 'acronym': 'PIPADN', 'briefTitle': 'Bonds Between Circulating Tumoral ADN (ctDNA) and the Development of Peritoneal Carcinomatosis for Patients Under PIPAC', 'organization': {'class': 'OTHER', 'fullName': 'Institut de Cancérologie de Lorraine'}, 'officialTitle': 'Study Evaluating the Bonds Between Circulating Tumoral ADN (ctDNA) and the Development of Peritoneal Carcinomatosis for Patients Treated With PIPAC', 'orgStudyIdInfo': {'id': '2021-A00645-36'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Blood sample (20ml) and Quality of Life Survey', 'interventionNames': ['Other: Blood sample (20 ml) and EORTC QLQC30 survey']}], 'interventions': [{'name': 'Blood sample (20 ml) and EORTC QLQC30 survey', 'type': 'OTHER', 'description': 'Blood sample (20ml) will be taken before and 24h after PIPAC procedure\n\nEORTC QLQC30 during pre operative consultation and at each post operative consultations', 'armGroupLabels': ['Blood sample (20ml) and Quality of Life Survey']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Vandœuvre-lès-Nancy', 'country': 'France', 'facility': 'Institut de Cancérologie de Lorraine', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}], 'overallOfficials': [{'name': 'Cécilia CERIBELLI, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut de Cancérologie de Lorraine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut de Cancérologie de Lorraine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}