Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2026-01-17 @ 7:50 PM
Study NCT ID:
NCT03874559
Status:
RECRUITING
Last Update Posted:
2024-10-16
First Post:
2019-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exosomes in Rectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012004', 'term': 'Rectal Neoplasms'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'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': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], '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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'blood serum samples will be collected from patients before, during, and after chemoradiation therapy. These samples will be analyzed and stored for 10 years'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'targetDuration': '1 Month', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-02-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-11', 'studyFirstSubmitDate': '2019-03-11', 'studyFirstSubmitQcDate': '2019-03-12', 'lastUpdatePostDateStruct': {'date': '2024-10-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Exosomal Biomarkers Assessment', 'timeFrame': 'up to 10 years after treatment completion', 'description': 'Characterize exosomal biomarker levels in patients with locally advanced rectal cancer undergoing neoadjuvant chemoradiation therapy.'}], 'secondaryOutcomes': [{'measure': 'Exosomal Expression', 'timeFrame': 'up to 10 years after treatment completion', 'description': 'Compare rates of exosomal expression before during and after chemoradiation therapy with pathologic response rates at the time of APR or LAR. Response rates will be graded based on College of American Pathologists Guidelines on neoadjuvant treatment effect, which consist of a 4 tiered grading system categorizing response to neoadjuvant chemoradiation as "complete", "moderate", "minimal", or "poor". These grades are routinely documented in pathology reports for patients undergoing neoadjuvant chemoradiation for rectal cancer and will be obtained from review of pathology reports in the patient medical records.'}, {'measure': 'Exosomal Functionality Assessment', 'timeFrame': 'up to 10 years after treatment completion', 'description': 'Examine the functionality of these exosomes in malignant colonic organoids and mouse models of colorectal cancer.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['neoadjuvant chemoradiation therapy', 'Low anterior resection', 'abdominoperineal resection', 'exosomes', 'biomarkers', 'external beam radiation'], 'conditions': ['Rectal Cancer']}, 'descriptionModule': {'briefSummary': 'The primary aims of this study is to characterize exosomal biomarker levels in patients with locally advanced rectal cancer undergoing neoadjuvant chemoradiation therapy. Compare rates of exosomal expression before during and after chemoradiation therapy with pathologic response rates at the time of APR or LAR. The researchers will also examine the functionality of these exosomes in malignant colonic organoids and mouse models of colorectal cancer.', 'detailedDescription': "All male and female patients, aged 18 and older with a histologically proven diagnosis of rectal adenocarcinoma, treated on this study will receive neo adjuvant chemotherapy (consisting of 5 FU or capecitabine) given concurrently with external beam radiation therapy to a dose of 50.4 Gy in 28 fractions. Radiation treatments will be administered daily, Monday thru Friday. Within one week prior to beginning chemotherapy and radiation treatments, a serum sample will be obtained from each patient. Patients will also have serum samples collected every two weeks during radiation, and on the last day of radiation therapy, as well as at their one month follow up visit after completion of radiation and prior to planned surgery. A final serum sample will be collected within one month after definitive surgery. Each serum sample collected will be less than 50 mL.\n\nThe study will involve obtaining serum samples from patients before during and after chemoradiation therapy. These serum samples will be analyzed to determine exosomal biomarker levels, which will be correlated with clinical, imaging, laboratory, and pathologic data obtained from the medical record.\n\nAdditional data from the patients' medical records will be collected, including demographic data, clinical information from notes in the medical record, radiology images and reports, results of diagnositic tests, and information from procedure notes and pathology reports."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients seen in the Department of Radiation Oncology at The University of Kansas Health System that are over the age of 18 and have a histologically proven diagnosis of rectal adenocarcinoma and will be receiving neoadjuvant chemoradiation therapy before a planned, definitive surgical resection has been performed.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and Female Patients aged 18 and older\n* histologically proven diagnosis of rectal adenocarcinoma\n* will be receiving neoadjuvant chemoradiation therapy prior to a planned definitive surgical resection\n\nExclusion Criteria:\n\n* Age less than 18.\n* Patients who are unable or unwilling to undergo definitive surgery.\n* Patients with a prior history of pelvic external beam radiation, brachytherapy, or chemotherapy.\n* Patients with a prior history of cancer (excluding non-melanoma skin cancers).\n* Patients who are immunocompromised.'}, 'identificationModule': {'nctId': 'NCT03874559', 'briefTitle': 'Exosomes in Rectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Kansas Medical Center'}, 'officialTitle': 'Exosomal As Correlative Biomarker in Clinical Outcomes in Patients Undergoing Neoadjuvant Chemoradiation Therapy for Rectal Cancer', 'orgStudyIdInfo': {'id': 'Protocol IIT-RE-0'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Arm A', 'description': 'All patients enrolled will be placed in Arm A. Serum blood draw samples will be collected as well as additional data from medical records will be collected. This data includes demographic data, clinical information from notes, radiology images and reports, diagnostic test results, and procedure and pathology reports.', 'interventionNames': ['Diagnostic Test: Blood Draw']}], 'interventions': [{'name': 'Blood Draw', 'type': 'DIAGNOSTIC_TEST', 'description': 'Serum samples will be obtained from each patient enrolled', 'armGroupLabels': ['Arm A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66190', 'city': 'Kansas City', 'state': 'Kansas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Leah Miller, MS', 'role': 'CONTACT', 'email': 'lmiller25@kumc.edu', 'phone': '913-588-3670'}, {'name': 'Mindi TenNapel, PhD', 'role': 'CONTACT', 'email': 'mtennapel@kumc.edu', 'phone': '913-945-9547'}, {'name': 'Andrew Hoover, MD', 'role': 'CONTACT'}], 'facility': 'University of Kansas Medical Center/ Cancer Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}], 'centralContacts': [{'name': 'Leah K Miller, MS', 'role': 'CONTACT', 'email': 'lmiller25@kumc.edu', 'phone': '913-588-3670'}, {'name': 'Michelle Faucheux, RN', 'role': 'CONTACT', 'email': 'mfaucheux@kumc.edu', 'phone': '913-588-9927'}], 'overallOfficials': [{'name': 'Andrew Hoover, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kansas Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Kansas Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Andrew Hoover', 'investigatorAffiliation': 'University of Kansas Medical Center'}}}}