Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 11:31 PM
Study NCT ID:
NCT05975593
Status:
RECRUITING
Last Update Posted:
2025-11-12
First Post:
2023-07-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
MicroEnvironment Tumor Effects of Radiotherapy - Comprehensive Radiobiology Assessment TRial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}, {'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}, {'id': 'D008279', 'term': 'Magnetic Resonance Imaging'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '30 cervical cancer patients and 30 pancreatic cancer patients'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2032-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-07', 'studyFirstSubmitDate': '2023-07-24', 'studyFirstSubmitQcDate': '2023-08-01', 'lastUpdatePostDateStruct': {'date': '2025-11-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-08-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2032-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in tumor microenvironment', 'timeFrame': 'From start of follow-up through completion of follow-up (estimated to be 5 years)', 'description': 'Generalized linear mixed effects models will be first used to capture the changes in the longitudinal values of a single assay output over time for a given biospecimen. Random effects will be used to describe the correlation of repeated measures on the same subject over time.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Radiotherapy', 'Chemotherapy', 'Cervical cancer', 'Pancreatic cancer', 'Biospecimen'], 'conditions': ['Locally Advanced Cervical Carcinoma', 'Locally Advanced Cervical Cancer', 'Locally Advanced Pancreas Cancer', 'Locally Advanced Pancreatic Carcinoma', 'Locally Advanced Pancreatic Cancer', 'Cervical Cancer', 'Pancreas Cancer', 'Pancreatic Cancer', 'Cancer of the Cervix', 'Cancer of the Pancreas']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.siteman.wustl.edu', 'label': 'Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine'}]}, 'descriptionModule': {'briefSummary': 'This study is a dynamically adjustable prospective longitudinal study designed to capture biospecimen (biopsy, blood, surgical) and multimodal treatment-related data (imaging, dosimetry, clinical) before, during, and after treatment with definitive-intent chemoradiotherapy for patients with locally advanced cervical and pancreatic cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmation of intent to receive radiotherapy for one of the following diagnoses:\n\n * Cervical cancer\n * Pancreatic cancer\n* ECOG performance status ≤ 2\n* At least 18 years old\n* Able to understand and willing to sign an IRB-approved written informed consent document\n\nExclusion Criteria:\n\n* Any issue (medical, anatomic, other) that might preclude safe acquisition of biospecimens at the discretion of the treating physician'}, 'identificationModule': {'nctId': 'NCT05975593', 'acronym': 'METEOR-CRATR', 'briefTitle': 'MicroEnvironment Tumor Effects of Radiotherapy - Comprehensive Radiobiology Assessment TRial', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'MicroEnvironment Tumor Effects of Radiotherapy - Comprehensive Radiobiology Assessment TRial (METEOR-CRATR)', 'orgStudyIdInfo': {'id': '202307103'}, 'secondaryIdInfos': [{'id': 'U54CA274318', 'link': 'https://reporter.nih.gov/quickSearch/U54CA274318', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Cervical Cancer', 'description': '* Patients will have blood and tumor collected at various time points throughout participation in the study.\n* Patients will have standard of care imaging obtained at various time points and a diffusion basis spectrum imaging (DBSI) MRI will be obtained at the end of standard of care MRI.', 'interventionNames': ['Other: Tumor collection via biopsy', 'Other: Blood collection', 'Device: Diffusion basis spectrum imaging (DBSI) magnetic resonance imaging (MRI)']}, {'type': 'OTHER', 'label': 'Pancreatic Cancer', 'description': '* Patients will have blood and tumor collected at various time points throughout participation in the study.\n* Patients will have standard of care imaging obtained at various time points and a diffusion basis spectrum imaging (DBSI) MRI will be obtained at the end of standard of care MRI.', 'interventionNames': ['Other: Tumor collection via biopsy', 'Other: Blood collection', 'Device: Diffusion basis spectrum imaging (DBSI) magnetic resonance imaging (MRI)']}], 'interventions': [{'name': 'Tumor collection via biopsy', 'type': 'OTHER', 'description': 'Cervical cancer: Pre-radiation therapy, 1 week after beginning radiation therapy, 3 weeks after beginning radiation therapy, and recurrence.\n\nPancreatic cancer: pre-stereotactic body radiotherapy, 12 weeks after completion of radiotherapy, and recurrence.', 'armGroupLabels': ['Cervical Cancer', 'Pancreatic Cancer']}, {'name': 'Blood collection', 'type': 'OTHER', 'description': 'Cervical cancer: pre-radiation therapy, 1 week after beginning radiation therapy, 3 weeks after beginning radiation therapy, 6 weeks after completing radiation therapy, 12 weeks after completing radiation therapy, and recurrence.\n\nPancreatic cancer: pre-stereotactic body radiotherapy, 6 weeks after completion of radiotherapy, 12 weeks after completion of radiotherapy, surgery (if applicable), and recurrence', 'armGroupLabels': ['Cervical Cancer', 'Pancreatic Cancer']}, {'name': 'Diffusion basis spectrum imaging (DBSI) magnetic resonance imaging (MRI)', 'type': 'DEVICE', 'otherNames': ['DBSI MRI'], 'description': 'Cervical cancer: initial staging, 12 weeks after completing radiation therapy, and recurrence.\n\nPancreatic cancer: initial staging, stereotactic body radiotherapy (SBRT) simulation, 12 weeks after completing radiation therapy, and recurrence.\n\nThe imaging will be performed when possible.', 'armGroupLabels': ['Cervical Cancer', 'Pancreatic Cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Cliff Robinson, M.D.', 'role': 'CONTACT', 'email': 'clifford.robinson@wustl.edu', 'phone': '314-362-8567'}, {'name': 'Cliff Robinson, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Carl DeSelm, M.D., Ph.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Stephanie Markovina, M.D., Ph.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Julie Schwarz, M.D., Ph.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jessika Contreras, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Dineo Khabele, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'David DeNardo, Ph.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Hyun Kim, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Kian-Huat Lim, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Hua Li, Ph.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Albert Lai, Ph.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Philip Payne, Ph.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Doug Caruthers, M.S.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Esther Lu, Ph.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Lei Liu, Ph.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Andrea Hagemann, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Lindsay Kuroki, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Leslie Stuart Massad, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Carolyn McCourt, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Maggie Mullen, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Matthew Powell, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Brooke Sanders, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Premal Thaker, M.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'centralContacts': [{'name': 'Cliff Robinson, M.D.', 'role': 'CONTACT', 'email': 'clifford.robinson@wustl.edu', 'phone': '314-362-8567'}], 'overallOfficials': [{'name': 'Cliff Robinson, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'Starting with the acceptance date of initial publication.', 'ipdSharing': 'YES', 'description': 'Data will be presented at scientific meetings \\& published in journals. Individual-level \\& aggregate genomic data will be deposited/made available through GEO \\& SRA. Includes sequence, transcriptomic, epigenomic, \\& gene expression data. Raw mass spectra \\& unprocessed proteomic data will be shared through publisher mechanisms. Will use PRIDE \\& ProteomeEXchange to share protein identifications \\& spectral evidence. METEOR-BLST will collaborate with ROBIN centers to share expertise, data reporting and discovering of radiation biology. Data generated in this proposal will be shared with the scientific community subject to NIH \\& institutional regulations. BLST will manage \\& assist in dissemination of omics data generated. NIMS data will be deposited at MetaboLights. CODEX-based imaging data will be as supplemental files within manuscripts. Processed data will be available through CIELO. Model organisms generated will be distributed freely, or deposited into a repository/stock center.', 'accessCriteria': "Scientific progress and publications will be posted on the METEOR website. The respective departments of the PIs and co-Is also maintain web sites where information and links on the investigators' work are posted. The PIs and co-Is additionally have lab web sites where summaries of the scientific progress on projects and research interests are posted."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, {'name': 'The Foundation for Barnes-Jewish Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}