Examining exosomes in patients with rectal cancer
Official title: Exosomal as Correlative Biomarker in Clinical Outcomes in Patients Undergoing Neoadjuvant Chemoradiation Therapy for Rectal Cancer
Run by University of Kansas Medical Center · NCT03874559 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | University of Kansas Medical Center Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Kansas City, Kansas) |
| Status | Recruiting |
| Started | February 13, 2018 |
| Main results expected | February 1, 2027 |
| Study ends | February 1, 2028 |
| Registry record updated | May 6, 2026 |
| Trial ID | NCT03874559 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.