Ignite Creation Date:
2025-12-25 @ 1:16 AM
Ignite Modification Date:
2025-12-25 @ 11:25 PM
Study NCT ID:
NCT05177393
Status:
RECRUITING
Last Update Posted:
2024-09-19
First Post:
2021-12-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Treatment Outcomes of Esophageal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004938', 'term': 'Esophageal Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2476}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-02-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-10', 'studyFirstSubmitDate': '2021-12-15', 'studyFirstSubmitQcDate': '2021-12-15', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of esophageal cancer (EC) participants receiving treatment with varying treatment modalities at participating AfrECC sites', 'timeFrame': 'Up to 4 years', 'description': 'Descriptive statistics will be used to describe the proportion of EC patients receiving treatment with each modality at participating AfrECC sites. The investigators will assess the associations between demographic and clinicopathologic characteristic and treatment modalities employed (chemotherapy, radiotherapy, chemo-radiation, esophageal stenting, esophagectomy, supportive care alone, or a combination of these treatments)'}, {'measure': 'Change in scores of the Modified Rosenblatt Index over time', 'timeFrame': 'Up to 4 years', 'description': 'The 6-item Modified Rosenblatt Index by Rosenblatt, et al. adapted for use within a resource-limited context evaluates EC related parameters scored on a Likert scale assessing presence and severity of symptoms: Odynophagia (0=no pain on swallowing to 3=severe pain); Dysphagia (0=normal, no dysphagia to 4=unable to swallow saliva); Regurgitation (0=never to 3=constant); Chest and/or Back Pain (0=no pain to 2=pain not relieved by non-narcotics or requiring opiate medication); World Health Organization (WHO) performance status/Overall Well-Being (0="A lot better" to 4="A lot worse"). Scores will be assessed at the following time points: Baseline, 1 month and 3 months after initiation of treatment, and every 3 months thereafter.'}, {'measure': 'Median Overall Survival', 'timeFrame': 'Up to 4 years', 'description': 'Survival will be defined as the time elapsed from date of diagnosis (either confirmed or date of diagnostic modality leading to presumptive clinical diagnosis) to date of death. For participants who are not deceased, censorship will be performed on the date when the participant was last known to be alive.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Treatment outcomes', 'Quality of life', 'Comparative effectiveness', 'Palliation'], 'conditions': ['Esophageal Cancer']}, 'referencesModule': {'references': [{'pmid': '41232057', 'type': 'DERIVED', 'citation': 'Mulima G, Mody GN, Kaimila B, Salima A, Williams B, Paciorek A, Zhang L, Charles A, Westmoreland KD, Van Loon K, Buckle GC. Treatment Outcomes of Esophageal Cancer in Malawi: An Analysis of Overall Survival and Patient-Reported Outcomes. JCO Glob Oncol. 2025 Nov;11:e2500221. doi: 10.1200/GO-25-00221. Epub 2025 Nov 13.'}, {'pmid': '35045815', 'type': 'DERIVED', 'citation': 'Buckle GC, Mrema A, Mwachiro M, Ringo Y, Selekwa M, Mulima G, Some FF, Mmbaga BT, Mody GN, Zhang L, Paciorek A, Akoko L, Ayuo P, Burgert S, Bukusi E, Charles A, Chepkemoi W, Chesumbai G, Kaimila B, Kenseko A, Kibwana KS, Koech D, Macharia C, Moirana EN, Mushi BP, Mremi A, Mwaiselage J, Mwanga A, Ndumbalo J, Nvakunga G, Ngoma M, Oduor M, Oloo M, Opakas J, Parker R, Seno S, Salima A, Servent F, Wandera A, Westmoreland KD, White RE, Williams B, Mmbaga EJ, Van Loon K; of the African Esophageal Cancer Consortium (AfrECC). Treatment outcomes of esophageal cancer in Eastern Africa: protocol of a multi-center, prospective, observational, open cohort study. BMC Cancer. 2022 Jan 19;22(1):82. doi: 10.1186/s12885-021-09124-5.'}]}, 'descriptionModule': {'briefSummary': 'This study will be a carried out through a prospective observational cohort design in conjunction with researchers in the African Esophageal Cancer Consortium (AfrECC). The purpose of this research is to prospectively evaluate outcomes related to existing treatment strategies for esophageal cancer (EC) at participating sites within AfrECC.', 'detailedDescription': 'SPECIFIC AIMS:\n\nAim 1: To describe the types of treatments administered for all patients diagnosed with EC at participating AfrECC sites, including chemotherapeutic regimens, radiation therapy, chemo-radiotherapy, esophageal stenting, esophagectomy, and basic supportive care.\n\nAim 2: To evaluate the effect of different EC treatment modalities on patient reported outcomes during and after completion of treatment.\n\nAim 3: To measure the effect of different treatment modalities on overall survival.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Participants with esophageal cancer based on histological confirmation or presumptive clinical diagnosis who reside in Kenya, Tanzania, and Malawi.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants with histopathologically confirmed or presumptive clinical diagnosis of EC. For patients who do not have histopathologically confirmed disease, presumptive clinical diagnosis may be based upon barium swallow or endoscopy without biopsy.\n* Age 18 years of age or older;\n\nExclusion Criteria:\n\n* Unable to provide informed consent'}, 'identificationModule': {'nctId': 'NCT05177393', 'briefTitle': 'Treatment Outcomes of Esophageal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Treatment Outcomes of Esophageal Cancer', 'orgStudyIdInfo': {'id': 'TOEC-AfrECC'}, 'secondaryIdInfos': [{'id': '21455', 'type': 'OTHER', 'domain': 'University of California, San Francisco'}, {'id': '184510', 'type': 'OTHER', 'domain': 'University of California, San Francisco'}, {'id': '214520', 'type': 'OTHER', 'domain': 'University of California, San Francisco'}, {'id': '204510', 'type': 'OTHER', 'domain': 'University of California, San Francisco'}, {'id': '184515', 'type': 'OTHER', 'domain': 'University of California, San Francisco'}, {'id': '3P30CA082103-21SA', 'link': 'https://reporter.nih.gov/quickSearch/3P30CA082103-21SA', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Participants with Esophageal Cancer', 'description': 'Participants with esophageal cancer will be administered questionnaires, and medical charts will be accessed to collect study related data.', 'interventionNames': ['Other: Assessment of patient-reported outcomes (PROs)']}], 'interventions': [{'name': 'Assessment of patient-reported outcomes (PROs)', 'type': 'OTHER', 'otherNames': ['PROs'], 'description': 'Questionnaires will be administered to participants', 'armGroupLabels': ['Participants with Esophageal Cancer']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bomet', 'status': 'RECRUITING', 'country': 'Kenya', 'contacts': [{'name': 'Michael Mwachiro, MBChB', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Tenwek Hospital', 'geoPoint': {'lat': -0.78129, 'lon': 35.34156}}, {'city': 'Eldoret', 'status': 'RECRUITING', 'country': 'Kenya', 'contacts': [{'name': 'Fatma F Some, MBChB, MMed', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Moi Teaching and Referral Hospital', 'geoPoint': {'lat': 0.52036, 'lon': 35.26993}}, {'city': 'Lilongwe', 'status': 'RECRUITING', 'country': 'Malawi', 'contacts': [{'name': 'Gift Mulima, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kamuzu Central Hospital', 'geoPoint': {'lat': -13.96692, 'lon': 33.78725}}, {'city': 'Dar es Salaam', 'status': 'RECRUITING', 'country': 'Tanzania', 'contacts': [{'name': 'Yona Ringo, MD, MMed', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Muhimbili National Hospital', 'geoPoint': {'lat': -6.82349, 'lon': 39.26951}}, {'city': 'Dar es Salaam', 'status': 'RECRUITING', 'country': 'Tanzania', 'contacts': [{'name': 'Alita Mrema, MD, MMed', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ocean Road Cancer Institute', 'geoPoint': {'lat': -6.82349, 'lon': 39.26951}}, {'city': 'Moshi', 'status': 'RECRUITING', 'country': 'Tanzania', 'contacts': [{'name': 'Blandina Mmbaga, MD, MMed,PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kilimanjaro Christian Medical Centre', 'geoPoint': {'lat': -3.35, 'lon': 37.33333}}], 'centralContacts': [{'name': 'Geoffrey Buckle, MD, MPH', 'role': 'CONTACT', 'email': 'geoffrey.buckle@ucsf.edu', 'phone': '(415) 476-1528'}], 'overallOfficials': [{'name': 'Geoffrey Buckle, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}, {'name': 'Katherine Van Loon, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'Westat', 'class': 'OTHER'}, {'name': 'African Esophageal Cancer Consortium (AfrECC)', 'class': 'UNKNOWN'}, {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, {'name': 'Celgene Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}