Patient case: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

Clinical trial: Circulating Tumor Cells in Patients With Rectal Cancer

Summary: 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.

Detailed description: Healthy Participants:
  If participant has 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 participant's blood is collected, their participation on this study will be over.
  This study is for research purposes only. Test results will not be placed in participant's medical record, and they will not be informed of the outcome of any test results.
  This is an investigational study.
  Up to 520 participants will be enrolled in this study. All will be enrolled at MD Anderson.
  Rectal Cancer Participants:
  If participant agrees to take part in this study, they will have blood drawn to test for CTCs.
  Rectal Cancer Participants:
  If patient is a participant who has been diagnosed with rectal (rectosigmoid) cancer, blood (about 2 tablespoons) may be drawn 1 time before participant starts 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 participant's surgery, or before they begin chemotherapy
  -  1-12 weeks after the last dose of chemotherapy
  -  1 year after participant's surgery (+/- 8 weeks) OR 1 year after completion of treatment if participant is not having surgery
  -  2 years after participant's surgery (+/- 8 weeks) OR 2 years after completion of treatment if participant is 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 participant's sample during testing AND they are still in one of the same timepoints listed above, participant 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 participant may need to come to the clinic for this.
  If participant chooses to receive follow-up care away from MD Anderson, they will be asked to allow study staff to contact them by phone or email. Participant will be asked about the status of the disease and they will be given instructions on how to provide blood samples for the time points above.
  This is an investigational study.
  Up to 520 participants will be enrolled in this study. All will take part at MD Anderson or its regional care centers.

Eligibility: 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) cancer, 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:

Relevance to patient case: not relevant