Circulating Tumor Cells in Patients With Locally Advanced Rectal Cancer

  • STATUS
    Recruiting
  • End date
    Sep 5, 2023
  • participants needed
    520
  • sponsor
    M.D. Anderson Cancer Center
Updated on 8 April 2021
adenocarcinoma

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). 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.

Description

PRIMARY OBJECTIVES:

I. 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.

Details
Condition Colorectal Cancer, Colorectal Cancer, Colon Cancer Screening, Colon cancer; rectal cancer, Rectal Cancer, Rectal Cancer, Colon Cancer Screening, Colon cancer; rectal cancer, Stage III Rectal Cancer AJCC v8, Stage IIIA Rectal Cancer AJCC v8, Stage IIIB Rectal Cancer AJCC v8, Stage IIIC Rectal Cancer AJCC v8, Stage IV Rectal Cancer AJCC v8, Stage IVA Rectal Cancer AJCC v8, Stage IVB Rectal Cancer AJCC v8, Stage IVC Rectal Cancer AJCC v8, Metastatic Rectal Adenocarcinoma, Recurrent Rectal Adenocarcinoma, Locally Advanced Rectal Adenocarcinoma, Rectosigmoid Adenocarcinoma, Recurrent Rectosigmoid Carcinoma
Treatment biospecimen collection, Blood draws
Clinical Study IdentifierNCT02874885
SponsorM.D. Anderson Cancer Center
Last Modified on8 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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