Ignite Creation Date:
2025-12-24 @ 5:12 PM
Ignite Modification Date:
2026-02-07 @ 12:49 PM
Study NCT ID:
NCT06550050
Status:
RECRUITING
Last Update Posted:
2025-10-24
First Post:
2024-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical and Molecular Features of Oral Premalignancy and Oral Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009062', 'term': 'Mouth Neoplasms'}], 'ancestors': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011827', 'term': 'Radiation'}, {'id': 'D004358', 'term': 'Drug Therapy'}], 'ancestors': [{'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2066-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-23', 'studyFirstSubmitDate': '2024-08-01', 'studyFirstSubmitQcDate': '2024-08-09', 'lastUpdatePostDateStruct': {'date': '2025-10-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2064-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MD Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN)', 'timeFrame': 'up to 5 years', 'description': "The MDASI-HN is a patient-reported outcome questionnaire designed to measure the severity or burden of systemic and head- and neck-specific symptoms and their interference with or effect on patients' daily functioning (Rosenthal, Mendoza et al. 2007, Cleeland 2016). This 28-item multi-symptom inventory is rated according to the last 24 hours at their worst, with 0 being symptoms not present and 10 being as bad as the patient can imagine. Cronbach alpha reliability ranges from 0.72 to 0.92."}], 'secondaryOutcomes': [{'measure': 'M.D. Anderson Dysphagia Inventory (MDADI)', 'timeFrame': 'up to 5 years', 'description': "The M.D. Anderson Dysphagia Inventory (MDADI) is a written questionnaire to evaluate dysphagia-specific QOL in head and neck cancer patients (Chen, Frankowski et al. 2001). Dysphagia (swallowing difficulty) is a top priority of HNC survivors and a driver of QOL after treatment. The 20-item MDADI questionnaire quantifies an individual's global, physical, emotional, and functional perceptions of his or her swallowing ability. In an internal validation in 100 patients with HNC, concurrent validity was found to be moderate by comparison with the Performance Status Scale (Spearman correlation, 0.47-0.61). Correlation with the physical functional subscale (Spearman correlation, 0.40) and emotional subscale of SF-36 (Spearman correlation, 0.36) demonstrated convergent and divergent validity, respectively, of the MDADI. Test-retest reliability (physical, 0.86; emotional, 0.88; functional, 0.88) and international consistency reliability (overall Cronbach's alpha, 0.96) were sound."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Oral Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'MD Anderson Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'Investigators will employ serial assessments of tissue biopsy and additional biomarkers that reflect burden of disease and predict treatment response. Patients enrolled on this study will be given the option to provide biological samples before, during, and after treatment, as well as functional outcomes of treatment response. These samples will be utilized to develop and validate prognostic and predictive biomarkers for patients undergoing targeted therapy, immunotherapy, surgery, chemotherapy, and/or radiotherapy.', 'detailedDescription': "Primary objectives: Current primary objectives need revision as they focus on diabetes which is not the focus of this study.\n\n* Investigators will examine the role of clinical, environmental, and genetic factors in increasing the risk of developing oral cancers and aggressive oral cancers.\n* To identify important environmental and clinical factors contributing to the risk of developing oral cancer or cancer progression\n* To identify genetic and molecular factors which contribute to increased risk of developing oral cancers through analysis of germline and somatic genetic alterations\n* Investigators will identify clinical and molecular predictors of diagnosis, treatment response, toxicity, and outcomes in patients with oral tumors.\n* To identify and validate clinical and molecular prognostic markers that may predict a patient's response to treatment\n* To identify and validate clinical and molecular prognostic markers that may predict a patient's risk of developing toxicity related to various modalities of treatment including but not limited to: targeted therapy, chemotherapy, radiation, surgery, and immunotherapy\n* To identify and validate clinical and molecular prognostic markers that may predict a patient's prognosis\n* To determine whether clinical and treatment factors influence patients' quality of life as assessed by validated self-report instruments routinely incorporated into clinical care pathways\n* To identify and validate molecular markers that may improve the diagnosis of oral premalignant or malignant tumors\n* To characterize acute and long-term function and quality of life after curative treatment(s)"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'MD Anderson Cancer Center', 'healthyVolunteers': False, 'eligibilityCriteria': '* Aged 18 or older, with a diagnosis of oral premalignant or malignant tumors (eligible diagnoses listed below) or presenting with suspected premalignant or malignant tumors for definitive diagnosis\n* Must be able to provide informed consent\n* Oral premalignant or malignant tumors presenting for evaluation for the first time at UT MD Anderson Cancer Center\n* Oral premalignant or malignant tumors who were previously treated or evaluated at UT MD Anderson Cancer Center who presents for evaluation of progressive or recurrent disease. Newly collected biospecimens and tissue samples will be linked to applicable samples previously collected and banked/stored under PA17-0050, LAB02-427, Lab02-039 and Lab08-0848.\n\nEligible diagnoses include:\n\n* Leukoplakia\n* Erythroplakia\n* Mild dysplasia\n* Moderate dysplasia\n* Severe dysplasia\n* Carcinoma in situ\n* Squamous cell carcinoma\n\nExclusion:\n\n\\- Pregnant women and/or cognitively-impaired adults are excluded from this study.\n\nExclusion Criteria:\n\n\\- Prior oral squamous cell carcinoma (OSCC) surgery or OSCC radiation treatment at a non-MDA institution.'}, 'identificationModule': {'nctId': 'NCT06550050', 'briefTitle': 'Clinical and Molecular Features of Oral Premalignancy and Oral Cancer', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'Clinical and Molecular Features of Oral Premalignancy and Oral Cancer Associated With Tumor Initiation, Aggressive Behavior, Treatment Response, and Survival Outcomes', 'orgStudyIdInfo': {'id': '2024-0307'}, 'secondaryIdInfos': [{'id': 'NCI-2024-06602', 'type': 'OTHER', 'domain': 'NIH-NCI'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Clinical and molecular features of oral premalignancy and oral cancer', 'interventionNames': ['Behavioral: Radiation']}], 'interventions': [{'name': 'Radiation', 'type': 'BEHAVIORAL', 'otherNames': ['Chemotherapy'], 'description': 'Standard of care', 'armGroupLabels': ['Clinical and molecular features of oral premalignancy and oral cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Xiao Zhao, MD', 'role': 'CONTACT', 'email': 'xzhao6@mdanderson.org', 'phone': '713-679-8704'}, {'name': 'Xiao Zhao, MD', 'role': 'CONTACT', 'email': 'xzhao6@mdanderson.org', 'phone': '(713) 679-8704'}], 'facility': 'MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Xiao Zhao, MD', 'role': 'CONTACT', 'email': 'xzhao6@mdanderson.org', 'phone': '(713) 679-8704'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}