Clinical trial NCT02874885: Circulating Tumor Cells in Patients With Locally Advanced Rectal Cancer
Official title: Circulating Tumor Elements in Patients With Rectal Cancer
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Locally Advanced Rectal Adenocarcinoma
Metastatic Rectal Adenocarcinoma
Rectosigmoid Adenocarcinoma
Recurrent Rectal Adenocarcinoma
Recurrent Rectosigmoid Carcinoma
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
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2016-08-22
Enrollment: 341
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy participants and patients diagnosed with rectal (or rectosigmoid) adenocarcinoma at MD Anderson Cancer Center.

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Proportion of treatment naive locally advanced rectal cancer (LARC) patients with circulating tumor cells (CTC)
timeFrame: Baseline up to 6 years
measure: Change in circulating tumor cells status
timeFrame: Baseline and 8 weeks after completion of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Yi-Qian N You
role: PRINCIPAL_INVESTIGATOR
References: