Exosomes in Rectal Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blood Draw.
- Who it may be relevant to
- Registry conditions: Rectal Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Exosomal as Correlative Biomarker in Clinical Outcomes in Patients Undergoing Neoadjuvant Chemoradiation Therapy for Rectal Cancer
Overview
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.
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.
Interventions
- Diagnostic test Blood Draw
Serum samples will be obtained from each patient enrolled
Primary outcome measures
- Exosomal Biomarkers Assessment [Time frame: up to 10 years after treatment completion]
Secondary outcome measures (2)
- Exosomal Expression [Time frame: up to 10 years after treatment completion]
- Exosomal Functionality Assessment [Time frame: up to 10 years after treatment completion]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- University of Kansas Medical Center/ Cancer Center — Kansas City
Identifiers
NCT: NCT03874559 · Protocol IIT-RE-0