Exosomes in Rectal Cancer
| Status: | Recruiting |
|---|---|
| Conditions: | Colorectal Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/16/2019 |
| Start Date: | February 13, 2018 |
| End Date: | February 1, 2022 |
| Contact: | Leah K Miller, MS |
| Email: | lmiller25@kumc.edu |
| Phone: | 913-588-3670 |
Exosomal as Correlative Biomarker in Clinical Outcomes in Patients Undergoing Neoadjuvant Chemoradiation Therapy for Rectal Cancer
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.
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.
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.
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.
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.
We found this trial at
1
site
Kansas City, Kansas 66205
Principal Investigator: Andrew Hoover, MD
Phone: 913-588-3670
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