Circulating Tumor Cells in Patients With Locally Advanced Rectal Cancer

M.D. Anderson Cancer Center

Status: Active, not recruiting

Conditions: Stage III Rectal Cancer AJCC v8; Stage IVB Rectal Cancer AJCC v8; Stage IIIC Rectal Cancer AJCC v8; Metastatic Rectal Adenocarcinoma; Recurrent Rectal Adenocarcinoma; Stage IIIA Rectal Cancer AJCC v8; Rectosigmoid Adenocarcinoma; Stage IVA Rectal Cancer AJCC v8; Stage IV Rectal Cancer AJCC v8; Stage IVC Rectal Cancer AJCC v8; Locally Advanced Rectal Adenocarcinoma; Recurrent Rectosigmoid Carcinoma; Stage IIIB Rectal Cancer AJCC v8

Treatments: Procedure: Biospecimen Collection

Study type: Observational

Funder types: Other

Identifiers

NCT02874885

PA13-0547 (Other Identifier)

NCI-2020-07460 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 341 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

341 participants in 1 patient group

Ancillary-Correlative (biospecimen collection)

Description:

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.

Treatment:

Procedure: Biospecimen Collection