Ignite Creation Date:
2025-12-24 @ 10:16 PM
Ignite Modification Date:
2026-01-05 @ 5:58 PM
Study NCT ID:
NCT04611035
Status:
UNKNOWN
Last Update Posted:
2022-04-06
First Post:
2020-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Q-GAIN (Using Qpop to Predict Treatment for GAstroIntestinal caNcer)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': '1.1 Tumour biopsies\n\n* maximum of 2 time points - baseline upon study enrolment and upon disease progression. Whenever possible, the tumour core biopsies will be performed under image guidance.\n* Up to 6 fresh core samples (each of Tumour and matched Adjacent-Normal/Non-Tumour) will be biopsied from each patient at each time-point.\n\n1.2 Blood -A total of 50ml or 3.5 tablespoons of blood will be taken during screening of the study. A total of 40mls or 2.5 tablespoons of blood will be taken prior to each chemotherapy cycle. At the end of study, a total of 40mls or 2.5 tablespoons of blood will be collected. In total, a maximum of about 330ml or 22 tablespoons of blood will be taken during the course of this study.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-01-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2023-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-04', 'studyFirstSubmitDate': '2020-08-26', 'studyFirstSubmitQcDate': '2020-10-26', 'lastUpdatePostDateStruct': {'date': '2022-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rates of radiological response', 'timeFrame': '3 years', 'description': 'complete and partial clinical response, including confidence intervals.'}, {'measure': 'Percentage of patients with successful organoid generation for each different tumour type.', 'timeFrame': '3 years', 'description': 'Patients enrolled on study will undergo a fresh biopsy of tumour lesion to obtain cells that will be used to generate patient-derived tumour organoids.'}, {'measure': 'Efficacy of second-line therapy', 'timeFrame': '3 years', 'description': 'measured by Overall Response Rate for patients with gastric cancer.'}], 'secondaryOutcomes': [{'measure': 'Haematologic and non-haematologic toxicities', 'timeFrame': '3 years', 'description': 'Toxicity rating using the NCI CTC v4.03 scale'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Qpop'], 'conditions': ['Gastrointestinal Cancer']}, 'referencesModule': {'references': [{'pmid': '22810696', 'type': 'RESULT', 'citation': 'Cancer Genome Atlas Network. Comprehensive molecular characterization of human colon and rectal cancer. Nature. 2012 Jul 18;487(7407):330-7. doi: 10.1038/nature11252.'}, {'pmid': '28572459', 'type': 'RESULT', 'citation': 'AACR Project GENIE Consortium. AACR Project GENIE: Powering Precision Medicine through an International Consortium. Cancer Discov. 2017 Aug;7(8):818-831. doi: 10.1158/2159-8290.CD-17-0151. Epub 2017 Jun 1.'}]}, 'descriptionModule': {'briefSummary': 'This is a multi-cohort proof of concept study involving patients with metastatic gastrointestinal cancers. In the first cohort of treatment-naïve patients, the investigators intend to create cancer organoids for 100 subjects. Then, the investigators intend to evaluate ex-vivo prediction of treatment outcomes using QPOP (see section 4.0 for detailed sample size calculation).\n\nPatients enrolled on study will undergo a fresh biopsy of tumour lesion to obtain cells that will be used to generate patient-derived tumour organoids. These patients will go on to receive standard of care first-line chemotherapy +/- targeted therapy. Organoids will then be subjected to up to a 14-drug panel screening. The drugs in the respective drug panel have been shown to have activity in the respective cancers and would be used in the standard-of-care setting by treating physicians.', 'detailedDescription': "Hypothesis: Ex-vivo sensitivity testing on patient derived tumour organoids using QPOP can identify drug combinations which may have clinical efficacy against metastatic gastrointestinal cancer.\n\nSpecific aim 1: To grow patients' gastrointestinal tumour-derived organoids.\n\nSpecific aim 2: To perform ex-vivo drug sensitivity testing on patient derived tumour organoids using QPOP for metastatic gastrointestinal cancers.\n\nSpecific aim 3: Asses the efficacy of phenotype directed therapy using QPOP to assign treatment after progression of standard of chemo for gastric cancer."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'At least 20 patients with gastric cancer, and 80 patients with other GI cancers will be first be recruited.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\-\n\nPatients may be included in the study only if they meet the following criteria:\n\n1. Treatment naïve patient with gastrointestinal cancers (i.e. oesophageal, gastro-oesophgeal, gastric, small bowel, colorectal, hepatocellular, pancreatic and biliary tract) fit and planned for first line treatment, OR\n2. Chemo-refractory patients with GI cancers deemed by investigator to be fit for clinical trial\n3. Age ≥ 21 years\n4. ECOG PS 0-1\n5. At least 1 tumour lesion amenable to fresh biopsy\n6. At least 1 measurable tumour lesion based on RECIST v 1.1 criteria\n7. Estimated life expectancy of at least 24 weeks\n8. Adequate organ function , including:\n\n 1. Pre-biopsy\n\n o Bone marrow:\n * Absolute neutrophil (segmented and bands) count (ANC) ≥1.5 x 109/L\n * Platelets ≥ 100 x 109/L\n * Pro-Thrombin within ULN\n * Hemoglobin ≥ 8 x 109/L\n 2. Pre-treatment\n\n * Bone marrow:\n\n * Absolute neutrophil (segmented and bands) count (ANC) ≥1.5 x 109/L\n * Platelets ≥ 100 x 109/L\n * Hemoglobin ≥ 8 x 109/L\n * Hepatic:\n\n * Bilirubin ≤ 1.5 x upper limit of normal (ULN),\n * ALT or AST ≤ 2.5x ULN, (or ≤ 5 X with liver metastases)\n * Renal:\n\n * Creatinine ≤ 1.5x ULN\n9. Signed informed consent from patient or legal representative\n10. Able to comply with study-related procedures.\n11. Recovery from prior toxicity to G1, excluding alopecia.\n\nExclusion Criteria:\n\n* There are no specific exclusion criteria if patients meet the inclusion criteria'}, 'identificationModule': {'nctId': 'NCT04611035', 'briefTitle': 'Q-GAIN (Using Qpop to Predict Treatment for GAstroIntestinal caNcer)', 'organization': {'class': 'OTHER', 'fullName': 'National University Hospital, Singapore'}, 'officialTitle': 'Q-GAIN (Using Qpop to Predict Treatment for GAstroIntestinal caNcer)', 'orgStudyIdInfo': {'id': '2019/00924'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patient', 'description': 'Patient with first-line gastrointestinal cancers and patient with advanced and refractory GI cancers (\\>1 line of treatment), or post-progression biopsy)', 'interventionNames': ['Device: QPOP']}], 'interventions': [{'name': 'QPOP', 'type': 'DEVICE', 'description': "QPOP will then be applied to establish the most efficacious drug combination for the specific organoid. Additional drugs other than those listed above may be screened depending on availability of cancer organoids. When patients progress after first-line treatment, QPOP generated second-line options will be informed to treating physicians and the physician will exercise his/her discretion to select the most suitable drug based on patient's comorbidities and organ function after a formal molecular/phenotype tumour board.", 'armGroupLabels': ['Patient']}]}, 'contactsLocationsModule': {'locations': [{'zip': '119074', 'city': 'Singapore', 'status': 'RECRUITING', 'country': 'Singapore', 'contacts': [{'name': 'Wei Peng Yong', 'role': 'CONTACT', 'email': 'Wei_Peng_Yong@nuhs.edu.sg', 'phone': '6779 5555'}], 'facility': 'National University Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'centralContacts': [{'name': 'Wei Peng Yong', 'role': 'CONTACT', 'email': 'Wei_Peng_Yong@nuhs.edu.sg', 'phone': '6779 5555'}], 'overallOfficials': [{'name': 'Wei Peng Yong', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National University Hospital, Singapore'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National University Hospital, Singapore', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}