Exosomes in Rectal Cancer
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|ClinicalTrials.gov Identifier: NCT03874559|
Recruitment Status : Recruiting
First Posted : March 14, 2019
Last Update Posted : March 14, 2019
|Condition or disease||Intervention/treatment|
|Rectal Cancer||Diagnostic Test: Blood Draw|
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.
The 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.
Additional 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.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||30 participants|
|Target Follow-Up Duration:||1 Month|
|Official Title:||Exosomal as Correlative Biomarker in Clinical Outcomes in Patients Undergoing Neoadjuvant Chemoradiation Therapy for Rectal Cancer|
|Actual Study Start Date :||February 13, 2018|
|Estimated Primary Completion Date :||February 1, 2021|
|Estimated Study Completion Date :||February 1, 2022|
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.
Diagnostic Test: Blood Draw
Serum samples will be obtained from each patient enrolled
- Exosomal Biomarkers Assessment [ Time Frame: up to 10 years after treatment completion ]Characterize exosomal biomarker levels in patients with locally advanced rectal cancer undergoing neoadjuvant chemoradiation therapy.
- Exosomal Expression [ Time Frame: up to 10 years after treatment completion ]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.
- Exosomal Functionality Assessment [ Time Frame: up to 10 years after treatment completion ]Examine the functionality of these exosomes in malignant colonic organoids and mouse models of colorectal cancer.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03874559
|Contact: Leah K Miller, MSemail@example.com|
|Contact: Michelle Faucheux, RNfirstname.lastname@example.org|
|United States, Kansas|
|University of Kansas Medical Center/ Cancer Center||Recruiting|
|Kansas City, Kansas, United States, 66190|
|Contact: Leah Miller, MS 913-588-3670 email@example.com|
|Contact: Mindi TenNapel, PhD 913-945-9547 firstname.lastname@example.org|
|Principal Investigator: Andrew Hoover, MD|
|Principal Investigator:||Andrew Hoover, MD||The University of Kansas Medical Center|