Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-26 @ 6:16 PM
Study NCT ID:
NCT04704960
Status:
UNKNOWN
Last Update Posted:
2021-01-14
First Post:
2021-01-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CirculAting Tumor DNA in Patients DIagnosed With Lung Metastasis From Colorectal Cancer: candiDate Selection for Local AblaTive thErapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'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'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': '20 mL of whole blood is collected and cell-free DNA is extracted'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-11', 'studyFirstSubmitDate': '2021-01-11', 'studyFirstSubmitQcDate': '2021-01-11', 'lastUpdatePostDateStruct': {'date': '2021-01-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'correlation between circulating tumor DNA (ctDNA) before and after local treatment (surgery or radiation) and recurrence of lung metastases from colorectal cancer', 'timeFrame': 'about 6 month but additional extension for patients with relapse after local treatment', 'description': 'The investigations investigate whether ctDNA changes and f/u ctDNA fraction after local treatment (surgery or radiation) can be useful as markers to predict the outcome of local treatments.'}], 'secondaryOutcomes': [{'measure': 'mutations related to target drug', 'timeFrame': 'about 6 month but additional extension for patients with relapse after local treatment', 'description': 'The investigations check for target drug related mutations from mutation profiling of ctDNA.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colorectal Cancer', 'Lung Metastases']}, 'descriptionModule': {'briefSummary': 'The investigators will detect circulating tumor DNA in blood of patients with lung metastases from colorectal cancer using NGS technology and intend to use it for predicting the outcome of local treatment (surgery or radiation) and recurrence of lung metastases.', 'detailedDescription': 'The investigators produce customized gene target panel by selecting genes that are commonly found in colorectal cancer and metastasis from existing literature.\n\nIn patients diagnosed with lung metastases from colorectal cancer, 20mL of whole blood is collected before and after local treatment (surgery or radiation) and cell-free DNA (cfDNA) is extracted from the collected blood. Thereafter, 20 mL of whole blood is additionally collected once after 3 months (±2 months) and once after 6 months (±2 months) during follow-up and cfDNA is extracted. The investigators perform sequencing from the extracted cfDNA.\n\nThe investigators compare the mutations detected in cfDNA before and after local treatment and identify the trend of reducing mutations in cfDNA after local treatment. So The investigators discover biomarkers for the outcome of local treatment. The investigators also search for mutations for target drugs from mutation profiling of cfDNA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'They were diagnosed with lung metastases from colorectal cancer and are Korean. They are also treated in severance hospital during the study period.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. adults over 19 years of age\n2. those who understand research and have written consent\n3. cases diagnosed with lung metastases from colorectal cancer\n\nExclusion Criteria:\n\n1. pregnant women, nursing women\n2. those who lack the ability to voluntarily agree\n3. participation in other clinical trials where drugs for clinical trials are administered within the past four weeks as of the date of participation in clinical trials'}, 'identificationModule': {'nctId': 'NCT04704960', 'acronym': 'CANDIDATE', 'briefTitle': 'CirculAting Tumor DNA in Patients DIagnosed With Lung Metastasis From Colorectal Cancer: candiDate Selection for Local AblaTive thErapy', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'officialTitle': 'CirculAting Tumor DNA in Patients DIagnosed With Lung Metastasis From Colorectal Cancer: candiDate Selection for Local AblaTive thErapy', 'orgStudyIdInfo': {'id': '4-2020-1176'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Lung metastases from colorectal cancer, local ablative therapy (surgery or radiation)', 'description': 'patients diagnosed with lung metastases from colorectal cancer and undergoing surgery or radiation for lumg metastasis', 'interventionNames': ['Other: Diagnostic Test: liquid biopsy']}], 'interventions': [{'name': 'Diagnostic Test: liquid biopsy', 'type': 'OTHER', 'description': 'detection of tumor DNA alteration in cf-DNA', 'armGroupLabels': ['Lung metastases from colorectal cancer, local ablative therapy (surgery or radiation)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'contacts': [{'name': 'Seung-Tae Lee', 'role': 'CONTACT', 'email': 'LEE.ST@yuhs.ac', 'phone': '82-2-2228-2446'}], 'facility': 'Department of Laboratory Medicine, Yonsei University College of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Seung-Tae Lee', 'role': 'CONTACT', 'email': 'LEE.ST@yuhs.ac', 'phone': '82-2-2228-2446'}], 'overallOfficials': [{'name': 'Seung-Tae Lee', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Severance Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}