Recruiting

Exosomes

Sponsor:

University of Kansas Medical Center

Code:

NCT03874559

Conditions

Rectal Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Blood Draw

Study Details

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.

Conditions

Rectal Cancer

Study ID

NCT03874559

Start date

Feb 13, 2018

Status verified date

Apr, 2026

Completion date

Feb 1, 2028

Anticipated

Primary completion date

Feb 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Blood Draw

Serum samples will be obtained from each patient enrolled

Primary outcome measure

  • Exosomal Biomarkers Assessment [ Time Frame: up to 10 years after treatment completion ]

Central Contacts and Locations

Central contacts

Leah K Miller, MS

913-588-3670lmiller25@kumc.edu

Michelle Faucheux, RN

913-588-9927mfaucheux@kumc.edu

Locations

University of Kansas Medical Center/ Cancer Center

Recruiting

Kansas City, Kansas, United States, 66190

Contacts

Leah Miller, MS

913-588-3670lmiller25@kumc.edu

Mindi TenNapel, PhD

913-945-9547mtennapel@kumc.edu

Principal Investigator:

Andrew Hoover, MD

More Information

Sponsor

University of Kansas Medical Center

Last update posted

May 6, 2026

Last verified

Apr, 2026

Keywords

  • neoadjuvant chemoradiation therapy
  • Low anterior resection
  • abdominoperineal resection
  • exosomes
  • biomarkers
  • external beam radiation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Kansas Medical Center on 2026-05-06.