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Trial record 41 of 127 for:    exosomes

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
Sponsor:
Information provided by (Responsible Party):
Andrew Hoover, University of Kansas Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment
Rectal Cancer Diagnostic Test: Blood Draw

Detailed Description:

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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Group/Cohort Intervention/treatment
Arm A
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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
blood serum samples will be collected from patients before, during, and after chemoradiation therapy. These samples will be analyzed and stored for 10 years


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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.
Criteria

Inclusion Criteria:

  • Male and Female Patients aged 18 and older
  • histologically proven diagnosis of rectal adenocarcinoma
  • will be receiving neoadjuvant chemoradiation therapy prior to a planned definitive surgical resection

Exclusion Criteria:

  • Age less than 18.
  • Patients who are unable or unwilling to undergo definitive surgery.
  • Patients with a prior history of pelvic external beam radiation, brachytherapy, or chemotherapy.
  • Patients with a prior history of cancer (excluding non-melanoma skin cancers).
  • Patients who are immunocompromised.

Information from the National Library of Medicine

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


Contacts
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Contact: Leah K Miller, MS 913-588-3670 lmiller25@kumc.edu
Contact: Michelle Faucheux, RN 913-588-9927 mfaucheux@kumc.edu

Locations
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United States, Kansas
University of Kansas Medical Center/ Cancer Center Recruiting
Kansas City, Kansas, United States, 66190
Contact: Leah Miller, MS    913-588-3670    lmiller25@kumc.edu   
Contact: Mindi TenNapel, PhD    913-945-9547    mtennapel@kumc.edu   
Principal Investigator: Andrew Hoover, MD         
Sponsors and Collaborators
University of Kansas Medical Center
Investigators
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Principal Investigator: Andrew Hoover, MD The University of Kansas Medical Center

Additional Information:

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Responsible Party: Andrew Hoover, Principle Investigator, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT03874559     History of Changes
Other Study ID Numbers: Protocol IIT-RE-0
First Posted: March 14, 2019    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Andrew Hoover, University of Kansas Medical Center:
neoadjuvant chemoradiation therapy
Low anterior resection
abdominoperineal resection
exosomes
biomarkers
external beam radiation
Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases