Examining exosomes in patients with rectal cancer
Exosomal as Correlative Biomarker in Clinical Outcomes in Patients Undergoing Neoadjuvant Chemoradiation Therapy for Rectal Cancer
This study is trying to see how certain markers in the blood change in people with locally advanced rectal cancer who are getting chemotherapy and radiation, and how these changes relate to their treatment response.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Kansas Medical Center Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Kansas City, Kansas) |
| Trial ID | NCT03874559 on ClinicalTrials.gov |
What this trial studies
This observational study aims to characterize exosomal biomarker levels in patients with locally advanced rectal cancer who are undergoing neoadjuvant chemoradiation therapy. Participants will receive chemotherapy alongside radiation treatment, with serum samples collected at various stages to analyze exosomal expression. The study will correlate these biomarker levels with clinical and pathologic responses to treatment, utilizing data from medical records and additional analyses in organoid and mouse models of colorectal cancer.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of rectal adenocarcinoma who are set to receive neoadjuvant chemoradiation therapy.
Not a fit: Patients under 18, those unable or unwilling to undergo surgery, or with a history of prior pelvic radiation or cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved biomarkers for monitoring treatment response in rectal cancer patients.
How similar studies have performed: While the approach of examining exosomal biomarkers is gaining traction, this specific study's methodology is relatively novel and has not been extensively tested in similar contexts.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Kansas City, Kansas
- University of Kansas Medical Center/ Cancer Center — Kansas City, Kansas, United States (Recruiting)
Study contacts
- Principal investigator: Andrew Hoover, MD — University of Kansas Medical Center
- Study coordinator: Leah K Miller, MS
- Email: lmiller25@kumc.edu
- Phone: 913-588-3670
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.