Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2025-12-25 @ 2:46 PM
Study NCT ID:
NCT07296250
Status:
RECRUITING
Last Update Posted:
2025-12-22
First Post:
2025-11-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Circulating Tumor Cell Counts in Postoperative ENE-Positive Oral Cavity Cancer Patients After Adjuvant CCRT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009062', 'term': 'Mouth Neoplasms'}, {'id': 'D009360', 'term': 'Neoplastic Cells, Circulating'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004358', 'term': 'Drug Therapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-08', 'studyFirstSubmitDate': '2025-11-21', 'studyFirstSubmitQcDate': '2025-12-08', 'lastUpdatePostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Circulating tumor cells (CTCs) testing', 'timeFrame': 'baseline', 'description': 'participants will undergo CTCs testing after completing concurrent Chemoradiotherapy (CCRT). If CTC-positive (≥5.0 cells/mL), participants will receive low-dose oral chemotherapy for three months, followed by repeat CTC testing. Persistent positivity will warrant continued treatment up to one year after curative surgery, while negativity will lead to treatment discontinuation.'}, {'measure': 'Circulating tumor cells (CTCs) testing', 'timeFrame': '3 month', 'description': 'participants will undergo CTCs testing after completing concurrent Chemoradiotherapy (CCRT). If CTC-positive (≥5.0 cells/mL), participants will receive low-dose oral chemotherapy for three months, followed by repeat CTC testing. Persistent positivity will warrant continued treatment up to one year after curative surgery, while negativity will lead to treatment discontinuation.'}, {'measure': 'Circulating tumor cells (CTCs) testing', 'timeFrame': '6 month', 'description': 'participants will undergo CTCs testing after completing concurrent Chemoradiotherapy (CCRT). If CTC-positive (≥5.0 cells/mL), participants will receive low-dose oral chemotherapy for three months, followed by repeat CTC testing. Persistent positivity will warrant continued treatment up to one year after curative surgery, while negativity will lead to treatment discontinuation.'}, {'measure': 'Circulating tumor cells (CTCs) testing', 'timeFrame': '9 month', 'description': 'participants will undergo CTCs testing after completing concurrent Chemoradiotherapy (CCRT). If CTC-positive (≥5.0 cells/mL), participants will receive low-dose oral chemotherapy for three months, followed by repeat CTC testing. Persistent positivity will warrant continued treatment up to one year after curative surgery, while negativity will lead to treatment discontinuation.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['oral cancer', 'ENE', 'Circulating tumor cells', 'Adjuvant concurrent Chemoradiation, adjuvant CCRT', 'Circulating tumor microemboli (CTM)'], 'conditions': ['Head and Neck Cancer', 'Oral Cancer']}, 'descriptionModule': {'briefSummary': 'The aim 1 of this trial is the development of the Circulating tumor cells (CTCs) definition of oral cancer minimal residual disease (MRD), and aim 2 is a prospective trial of oral cancer treatment. If this trial is successful, it is expected that it may be able to provide a standard diagnostic tool (MRD in Oral Cavity Squamous Cell Carcinoma (OCSCC)) and treatment mode (extended adjuvant chemotherapy with low-dose oral chemotherapy). The survival rate of patients will be improved.', 'detailedDescription': 'The aim 1 of this trial is the development of the CTC definition of oral cancer MRD, and aim 2 is a prospective trial of oral cancer treatment. If this trial is successful, it is expected that it may be able to provide a standard diagnostic tool (MRD in OCSCC) and treatment mode (extended adjuvant chemotherapy with low-dose oral chemotherapy). The survival rate of patients will be improved.\n\nThis three-year study is expected to recruit 100 oral cavity cancer patients with extracapsular nodal extension (ENE) or other postoperative risks.10 mL of research blood was drawn four times in total.Each patient must continue to be tracked for ENE or other postoperative risks for one year, and with blood testing every tree month.\n\nFor the negative selection of CTCs by the negative selection system. For the positive selection of CTCs by counting Epithelial cell adhesion molecule(EpCAM)-positive and Hoechst-positive cells under a microscope with a hemocytometer.\n\nIn brief, CTC could predict a poor prognosis in HNSCC patients. But the role of longitudinal CTC follow-up in ENE+ oral cavity cancer patients remains unclear.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nParticipants with Cancer:\n\n1. Aged between 18 and 90 years.\n2. Histologically confirmed diagnosis of head and neck squamous cell carcinoma (HNSCC).\n3. Completed surgical treatment and identified as having high-risk factors, followed by concurrent chemoradiotherapy.\n4. Willing to continue follow-up visits at the hospital after completion of treatment.\n\nExclusion Criteria:\n\n1. Presence of psychiatric disorders.\n2. Deemed unsuitable for participation by the attending physician.\n3. Unwilling to participate in the study.'}, 'identificationModule': {'nctId': 'NCT07296250', 'briefTitle': 'Circulating Tumor Cell Counts in Postoperative ENE-Positive Oral Cavity Cancer Patients After Adjuvant CCRT', 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung Memorial Hospital'}, 'officialTitle': 'A Randomized, Prospective Phase II Clinical Trial - Extended Chemotherapy or Not Based on Circulating Tumor Cell Counts in Postoperative ENE-Positive Oral Cavity Cancer Patients After Completing Adjuvant Concurrent Chemoradiotherapy', 'orgStudyIdInfo': {'id': '202402125B0'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'control', 'description': 'participants without low-dose oral chemotherapy. Each patient must continue to be tracked for ENE or other postoperative risks for one year, and with blood testing every tree month.'}, {'type': 'EXPERIMENTAL', 'label': 'experimental', 'description': 'participants with low-dose oral chemotherapy. Each patient must continue to be tracked for ENE or other postoperative risks for one year, and with blood testing every tree month.', 'interventionNames': ['Procedure: low-dose oral chemotherapy']}], 'interventions': [{'name': 'low-dose oral chemotherapy', 'type': 'PROCEDURE', 'description': 'recruit 100 oral cavity cancer patients with ENE or other postoperative risks.10 mL of research blood was drawn four times in total.Each patient must continue to be tracked for ENE or other postoperative risks for one year, and with blood testing every tree month.', 'armGroupLabels': ['experimental']}]}, 'contactsLocationsModule': {'locations': [{'zip': '333423', 'city': 'Taoyuan', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'ChunTa Liao, PhD', 'role': 'CONTACT', 'email': 'liaoct@cgmh.org.tw', 'phone': '0975360141'}, {'name': 'ChiaHsun Hsieh, PhD', 'role': 'CONTACT', 'email': 'wisdom5000@cgmh.org.tw', 'phone': '0975366137'}], 'facility': 'Linkou Chang Gung Memorial Hospital', 'geoPoint': {'lat': 24.99368, 'lon': 121.29696}}], 'centralContacts': [{'name': 'ChunTa Liao, PhD', 'role': 'CONTACT', 'email': 'liaoct@cgmh.org.tw', 'phone': '0975360141'}, {'name': 'Chia-Hsun Hsieh, PhD', 'role': 'CONTACT', 'email': 'wisdom5000@cgmh.org.tw', 'phone': '0975366137'}], 'overallOfficials': [{'name': 'ChunTa Liao, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Division of Otolaryngology, Chang Gung Memorial Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Attending Physicians', 'investigatorFullName': 'Chun-Ta Liao', 'investigatorAffiliation': 'Chang Gung Memorial Hospital'}}}}