Rectal CancerNCT03874559
Exosomes in Rectal Cancer
An observational study of Rectal Cancer, run by University of Kansas Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Blood Draw
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2018to 1 Feb 2028
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients seen in the Department of Radiation Oncology at The University of Kansas Health System that are over the age of 18 and have a histologically proven diagnosis of rectal adenocarcinoma and will be receiving neoadjuvant chemoradiation therapy before a planned, definitive surgical resection has been performed.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Kansas Medical Center/ Cancer Center
Kansas City, Kansas, 66190
Leah Miller, MS, 913-588-3670, lmiller25@kumc.edu
Mindi TenNapel, PhD, 913-945-9547, mtennapel@kumc.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Rectal Cancer
- Being tested
- Blood Draw
- Keywords
- neoadjuvant chemoradiation therapy, Low anterior resection, abdominoperineal resection, exosomes, biomarkers, external beam radiation
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood DrawDiagnostic test
Serum samples will be obtained from each patient enrolled
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Blood Draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exosomal Biomarkers Assessment
Characterize exosomal biomarker levels in patients with locally advanced rectal cancer undergoing neoadjuvant chemoradiation therapy.
Measured: up to 10 years after treatment completion
Secondary outcomes (2)
Exosomal Expression
Compare rates of exosomal expression before during and after chemoradiation therapy with pathologic response rates at the time of APR or LAR. Response rates will be graded based on College of American Pathologists Guidelines on neoadjuvant treatment effect, which consist of a 4 tiered grading system categorizing response to neoadjuvant chemoradiation as "complete", "moderate", "minimal", or "poor". These grades are routinely documented in pathology reports for patients undergoing neoadjuvant chemoradiation for rectal cancer and will be obtained from review of pathology reports in the patient medical records.
Measured: up to 10 years after treatment completion
Exosomal Functionality Assessment
Examine the functionality of these exosomes in malignant colonic organoids and mouse models of colorectal cancer.
Measured: up to 10 years after treatment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2019
- Study start13 Feb 2018
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Hoover, University of Kansas Medical Center
- Investigators
- Andrew Hoover, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03874559
- Sponsor's protocol ID
- Protocol IIT-RE-0
- Status last verified
- Apr 2026
- First submitted
- 11 Mar 2019
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exosomal as Correlative Biomarker in Clinical Outcomes in Patients Undergoing Neoadjuvant Chemoradiation Therapy for Rectal Cancer
- ClinicalTrials.gov ID
- NCT03874559
- Acronym / sponsor ID
- Protocol IIT-RE-0
- Conditions
- Rectal Cancer
- Keywords
- neoadjuvant chemoradiation therapy, Low anterior resection, abdominoperineal resection, exosomes, biomarkers, external beam radiation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 13 Feb 2018 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 14 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm A | – | Diagnostic Test: Blood DrawAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients seen in the Department of Radiation Oncology at The University of Kansas Health System that are over the age of 18 and have a histologically proven diagnosis of rectal adenocarcinoma and will be receiving neoadjuvant chemoradiation therapy before a planned, definitive surgical resection has been performed.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood DrawSerum samples will be obtained from each patient enrolled | Diagnostic test | Arm A |
Primary outcome
Exosomal Biomarkers Assessment
Time frame: up to 10 years after treatment completion
Characterize exosomal biomarker levels in patients with locally advanced rectal cancer undergoing neoadjuvant chemoradiation therapy.
2 secondary outcomes
Exosomal Expression
Time frame: up to 10 years after treatment completion
Exosomal Functionality Assessment
Time frame: up to 10 years after treatment completion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrew Hoover, MD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Cancer, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Leah K Miller, MS (913-588-3670, lmiller25@kumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exosomal Biomarkers Assessment (time frame: up to 10 years after treatment completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.