Locally Advanced Rectal AdenocarcinomaNCT02874885
Circulating Tumor Cells in Patients With Locally Advanced Rectal Cancer
An observational study of Locally Advanced Rectal Adenocarcinoma and Metastatic Rectal Adenocarcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This study looks at the level of circulating tumor elements (cancer cells or DNA pieces floating in the blood) and how it may be related to how the tumor responds to standard treatment in patients with rectal cancer that has spread to nearby tissue or lymph nodes (locally advanced). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Locally Advanced Rectal Adenocarcinoma, Metastatic Rectal Adenocarcinoma, Rectosigmoid Adenocarcinoma
- What is being tested?
- Biospecimen Collection
- Type of treatment
- Surgery or procedure
- How many people
- 341 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Sep 2013to 30 Apr 2027
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy participants and patients diagnosed with rectal (or rectosigmoid) adenocarcinoma at MD Anderson Cancer Center.
Who may be able to join
- HEALTHY SUBJECT: No known diagnosis of colorectal cancer (CRC) or any other type of cancer for the last 10 years.(basal cell skin cancer is allowed). Subjects will be asked about their cancer history and a verbal confirmation is required
- Any patient with diagnosis of rectal (or rectosigmoid) adenocarcinoma, including:
- Patients with primary disease with or without neoadjuvant therapy; OR
- Patients with recurrent disease with or without neoadjuvant therapy; OR
- Patients with metastatic disease with or without prior treatment
- No known current diagnosis of other invasive cancer; if prior diagnosis of other cancer, he/she has been free from cancer for >= 3 years and is on no active treatment
- Adequate mental and language capacity to provide consent
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Circulating Tumor Elements in Patients With Rectal Cancer
This study looks at the level of circulating tumor elements (cancer cells or DNA pieces floating in the blood) and how it may be related to how the tumor responds to standard treatment in patients with rectal cancer that has spread to nearby tissue or lymph nodes (locally advanced). Researchers will also compare the level and genetic characteristics of circulating tumor elements between individuals with rectal cancer and healthy individuals to understand how they may change over time. Information from this study may help researchers better understand rectal cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- To establish the rate of circulating tumor elements (CTE), including but not limited to circulating tumor cells and circulating tumor deoxyribonucleic acid (DNA) detection in patients with locally advanced rectal cancer (LARC), relative to other stages.
II. To assess changes in detected CTEs associated with neoadjuvant therapy in patients with LARC.
III. To correlate CTEs with neoadjuvant treatment response as an indicator of disease risk.
OUTLINE:
Patients and healthy participants undergo collection of blood sample at baseline. Patients may also undergo collection of blood sample collections during tumor surgery, 4 weeks after surgery or after completion of treatment if you are not surgery, 8 weeks after the last dose of chemotherapy, 1 year after surgery or 1 year after completion of treatment if not having surgery, 2 years after surgery or 2 years after completion of treatment if not having surgery, and within 6 years after treatment or at the end of the 6 year follow-up if the disease gets worse with treatment or comes back.
- Conditions
- Locally Advanced Rectal Adenocarcinoma, Metastatic Rectal Adenocarcinoma, Rectosigmoid Adenocarcinoma, Recurrent Rectal Adenocarcinoma, Recurrent Rectosigmoid Carcinoma, Stage III Rectal Cancer AJCC v8
- Being tested
- Biospecimen Collection
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Undergo collection of blood sample
| Study group | Role | What they receive |
|---|---|---|
| Ancillary-Correlative (biospecimen collection) | Patients and healthy participants undergo collection of blood sample at baseline. Patients may also undergo collection of blood sample collections during tumor surgery, 4 weeks after surgery or after completion of treatment if you are not surgery, 8 weeks after the last dose of chemotherapy, 1 year after surgery or 1 year after completion of treatment if not having surgery, 2 years after surgery or 2 years after completion of treatment if not having surgery, and within 6 years after treatment or at the end of the 6 year follow-up if the disease gets worse with treatment or comes back. Receives: Procedure: Biospecimen Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of treatment naive locally advanced rectal cancer (LARC) patients with circulating tumor cells (CTC)
The proportion of patients with any CTC will be calculated with a 95% confidence interval (CI). Additionally, the actual CTC count will be plotted with a box-plot. Proportions of patients with 2 or more, and 3 or more CTCs will be calculated. Will also explore correlations between the presence of 1 or more CTC and primary tumor characteristics using Chi-Squared or Fischer's exact tests as appropriate.
Measured: Baseline up to 6 years
Change in circulating tumor cells status
A McNemar's test will be used to test whether neoadjuvant therapy (NEO) provided any improvement in the proportion of patients with any CTC. The CTC counts at baseline versus 8 weeks after completion of treatment will be compared with a paired t-test.
Measured: Baseline and 8 weeks after completion of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2016 (estimated)
- Study start5 Sep 2013
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Rectal AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- 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
- 341 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yi-Qian N You, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02874885
- Sponsor's protocol ID
- PA13-0547
- Other IDs
- NCI-2020-07460, PA13-0547
- Status last verified
- Sep 2026
- First submitted
- 17 Aug 2016
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating Tumor Elements in Patients With Rectal Cancer
- ClinicalTrials.gov ID
- NCT02874885
- Acronym / sponsor ID
- PA13-0547
- Conditions
- Locally Advanced Rectal Adenocarcinoma, Metastatic Rectal Adenocarcinoma, Rectosigmoid Adenocarcinoma, Recurrent Rectal Adenocarcinoma, Recurrent Rectosigmoid Carcinoma, Stage III Rectal Cancer AJCC v8
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 341 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 5 Sep 2013 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 22 Aug 2016 (estimated)
- 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.
This study looks at the level of circulating tumor elements (cancer cells or DNA pieces floating in the blood) and how it may be related to how the tumor responds to standard treatment in patients with rectal cancer that has spread to nearby tissue or lymph nodes (locally advanced). Researchers will also compare the level and genetic characteristics of circulating tumor elements between individuals with rectal cancer and healthy individuals to understand how they may change over time. Information from this study may help researchers better understand rectal cancer.
Detailed description
PRIMARY OBJECTIVES:
- To establish the rate of circulating tumor elements (CTE), including but not limited to circulating tumor cells and circulating tumor deoxyribonucleic acid (DNA) detection in patients with locally advanced rectal cancer (LARC), relative to other stages.
II. To assess changes in detected CTEs associated with neoadjuvant therapy in patients with LARC.
III. To correlate CTEs with neoadjuvant treatment response as an indicator of disease risk.
OUTLINE:
Patients and healthy participants undergo collection of blood sample at baseline. Patients may also undergo collection of blood sample collections during tumor surgery, 4 weeks after surgery or after completion of treatment if you are not surgery, 8 weeks after the last dose of chemotherapy, 1 year after surgery or 1 year after completion of treatment if not having surgery, 2 years after surgery or 2 years after completion of treatment if not having surgery, and within 6 years after treatment or at the end of the 6 year follow-up if the disease gets worse with treatment or comes back.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ancillary-Correlative (biospecimen collection) | – | Procedure: Biospecimen CollectionPatients and healthy participants undergo collection of blood sample at baseline. Patients may also undergo collection of blood sample collections during tumor surgery, 4 weeks after surgery or after completion of treatment if you are not surgery, 8 weeks after the last dose of chemotherapy, 1 year after surgery or 1 year after completion of treatment if not having surgery, 2 years after surgery or 2 years after completion of treatment if not having surgery, and within 6 years after treatment or at the end of the 6 year follow-up if the disease gets worse with treatment or comes back. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy participants and patients diagnosed with rectal (or rectosigmoid) adenocarcinoma at MD Anderson Cancer Center.
Key inclusion criteria (7 listed)
- HEALTHY SUBJECT: No known diagnosis of colorectal cancer (CRC) or any other type of cancer for the last 10 years.(basal cell skin cancer is allowed). Subjects will be asked about their cancer history and a verbal confirmation is required
- Any patient with diagnosis of rectal (or rectosigmoid) adenocarcinoma, including:
- No known current diagnosis of other invasive cancer; if prior diagnosis of other cancer, he/she has been free from cancer for >= 3 years and is on no active treatment
- Adequate mental and language capacity to provide consent
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Biospecimen CollectionUndergo collection of blood sample | Procedure or surgery | Ancillary-Correlative (biospecimen collection) |
Primary outcome
Proportion of treatment naive locally advanced rectal cancer (LARC) patients with circulating tumor cells (CTC)
Time frame: Baseline up to 6 years
The proportion of patients with any CTC will be calculated with a 95% confidence interval (CI). Additionally, the actual CTC count will be plotted with a box-plot. Proportions of patients with 2 or more, and 3 or more CTCs will be calculated. Will also explore correlations between the presence of 1 or more CTC and primary tumor characteristics using Chi-Squared or Fischer's exact tests as appropriate.
Change in circulating tumor cells status
Time frame: Baseline and 8 weeks after completion of treatment
A McNemar's test will be used to test whether neoadjuvant therapy (NEO) provided any improvement in the proportion of patients with any CTC. The CTC counts at baseline versus 8 weeks after completion of treatment will be compared with a paired t-test.
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 18 Sep 2026.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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. This study is not recruiting at the moment.
Yi-Qian N You principal investigator
M.D. Anderson Cancer 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 Locally Advanced Rectal Adenocarcinoma and Metastatic Rectal Adenocarcinoma, run by M.D. Anderson Cancer 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 7 inclusion and 0 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: under way, not looking for participants, as of the sponsor's last update on 18 Sep 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of treatment naive locally advanced rectal cancer (LARC) patients with circulating tumor cells (CTC) (time frame: Baseline up to 6 years). The study lists 2 primary outcomes in all. 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 18 Sep 2026.