Houston, Texas 77030


Objectives: - To establish the rate of circulating tumor cells (CTC) positivity in patients with locally-advanced rectal cancer (LARC), relative to other stages; - To assess changes in detected CTCs associated with neoadjuvant therapy in patients with LARC; - To correlate CTC counts with neoadjuvant treatment response as an indicator of disease risk.

Study summary:

Healthy Participants: If you have not been diagnosed with colorectal cancer, blood (about 2 tablespoons) will be drawn 1 time. This blood will be used as a control (normal) to look for differences in cells in the blood of patients with colorectal cancer. Once your blood is collected, your participation on this study will be over. This study is for research purposes only. Test results will not be placed in your medical record, and you will not be informed of the outcome of any test results. enrolled in this study. All will be enrolled at MD Anderson. Rectal Cancer Participants: If you agree to take part in this study, you will have blood drawn to test for CTCs. Rectal Cancer Participants: If you are a participant who has been diagnosed with rectal (rectosigmoid) cancer, blood (about 2 tablespoons) may be drawn 1 time before you start treatment. Additional Blood Draws for Rectal Cancer Patients ONLY: Blood (about 2 tablespoons) may also be drawn for CTC and other testing at the following time points: - Just before tumor surgery - 1-8 weeks after your surgery, or before you begin chemotherapy - 1-12 weeks after the last dose of chemotherapy - 1 year after your surgery (+/- 12 weeks) OR 1 year after completion of treatment if you are not having surgery - 2 years after your surgery (+/- 12 weeks) OR 2 years after completion of treatment if you are not having surgery - If the disease gets worse during treatment OR If the disease comes back within 6 years after treatment OR at end of 6 years follow-up If there is a problem with your sample during testing AND you are still in one of the same timepoints listed above, you may be asked to provide extra blood (about 2 tablespoons) to complete the study testing. Whenever possible, this blood draw will be done as part of a routine blood draw, but you may need to come to the clinic for this. If you choose to receive follow-up care away from MD Anderson, you will be asked to allow study staff to contact you by phone or email. You will be asked about the status of the disease and you will be given instructions on how to provide blood samples for the time points above. Some of your processed blood samples and data may be sent to Natera for additional testing related to this study. No identifying information about you will be included with these samples. They will have a special number assigned so that the samples will not be connected back to you by anyone outside of the research team at MD Anderson.


Inclusion Criteria: 1. Adult participants (Age >/= 18 years old) 2. Meets one of the following definitions: 1. 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. 2. 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 3. No known current diagnosis of other cancer; if prior diagnosis of other cancer, he/she has been free from cancer for >/= 6 years and is on no active treatment. 4. Adequate mental and language capacity to provide consent. Exclusion Criteria: N/A



Primary Contact:

Principal Investigator
Yi-Qian N. You, MD
M.D. Anderson Cancer Center

Yi-Qian N. You, MD
Phone: 713-792-6940
Email: YNYou@mdanderson.org

Backup Contact:


Location Contact:

Houston, Texas 77030
United States

There is no listed contact information for this specific location.

Site Status: Recruiting

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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