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Circulating Tumor Cells in Patients With Rectal Cancer

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ClinicalTrials.gov Identifier: NCT02874885
Recruitment Status : Recruiting
First Posted : August 22, 2016
Last Update Posted : May 29, 2019
Sponsor:
Collaborator:
Research Foundation of the American Society of Colon and Rectal Surgeons
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief 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.

Condition or disease Intervention/treatment
Rectal Cancer Procedure: Blood Draws

Detailed Description:

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.


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Study Type : Observational
Estimated Enrollment : 520 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Circulating Tumor Cells in Patients With Rectal Cancer
Actual Study Start Date : September 2013
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : September 2024

Group/Cohort Intervention/treatment
Healthy Participants
Blood (about 2 tablespoons) drawn at 1 time point.
Procedure: Blood Draws

Healthy Participants: Blood (about 2 tablespoons) drawn at 1 time point.

Rectal Cancer Participants: Blood (about 2 tablespoons) drawn 1 time before participant starts treatment.

Blood also drawn:

Just before tumor surgery 1-8 weeks after surgery, or before chemotherapy begins 1-12 weeks after last dose of chemotherapy

  1. year after surgery, OR 1 year after completion of treatment if no surgery
  2. years after surgery, OR 2 years after completion of treatment if no surgery If the disease gets worse during treatment, OR If disease comes back within 6 years after treatment, OR at end of 6 years follow-up.
Other Names:
  • Blood collection
  • Blood Sample

Primary Disease w/wo Neoadjuvant Therapy

Blood (about 2 tablespoons) drawn 1 time before participant starts treatment.

Blood also drawn:

  • Just before tumor surgery
  • 1-8 weeks after surgery, or before chemotherapy begins
  • 1-12 weeks after last dose of chemotherapy
  • 1 year after surgery, OR 1 year after completion of treatment if no surgery
  • 2 years after surgery, OR 2 years after completion of treatment if no surgery
  • If the disease gets worse during treatment, OR If disease comes back within 6 years after treatment, OR at end of 6 years follow-up.
Procedure: Blood Draws

Healthy Participants: Blood (about 2 tablespoons) drawn at 1 time point.

Rectal Cancer Participants: Blood (about 2 tablespoons) drawn 1 time before participant starts treatment.

Blood also drawn:

Just before tumor surgery 1-8 weeks after surgery, or before chemotherapy begins 1-12 weeks after last dose of chemotherapy

  1. year after surgery, OR 1 year after completion of treatment if no surgery
  2. years after surgery, OR 2 years after completion of treatment if no surgery If the disease gets worse during treatment, OR If disease comes back within 6 years after treatment, OR at end of 6 years follow-up.
Other Names:
  • Blood collection
  • Blood Sample

Recurrent Disease w/wo Neoadjuvant Therapy

Blood (about 2 tablespoons) drawn 1 time before participant starts treatment.

Blood also drawn:

  • Just before tumor surgery
  • 1-8 weeks after surgery, or before chemotherapy begins
  • 1-12 weeks after last dose of chemotherapy
  • 1 year after surgery, OR 1 year after completion of treatment if no surgery
  • 2 years after surgery, OR 2 years after completion of treatment if no surgery
  • If the disease gets worse during treatment, OR If disease comes back within 6 years after treatment, OR at end of 6 years follow-up.
Procedure: Blood Draws

Healthy Participants: Blood (about 2 tablespoons) drawn at 1 time point.

Rectal Cancer Participants: Blood (about 2 tablespoons) drawn 1 time before participant starts treatment.

Blood also drawn:

Just before tumor surgery 1-8 weeks after surgery, or before chemotherapy begins 1-12 weeks after last dose of chemotherapy

  1. year after surgery, OR 1 year after completion of treatment if no surgery
  2. years after surgery, OR 2 years after completion of treatment if no surgery If the disease gets worse during treatment, OR If disease comes back within 6 years after treatment, OR at end of 6 years follow-up.
Other Names:
  • Blood collection
  • Blood Sample

Metastatic Disease w/wo Prior Treatment

Blood (about 2 tablespoons) drawn 1 time before participant starts treatment.

Blood also drawn:

  • Just before tumor surgery
  • 1-8 weeks after surgery, or before chemotherapy begins
  • 1-12 weeks after last dose of chemotherapy
  • 1 year after surgery, OR 1 year after completion of treatment if no surgery
  • 2 years after surgery, OR 2 years after completion of treatment if no surgery
  • If the disease gets worse during treatment, OR If disease comes back within 6 years after treatment, OR at end of 6 years follow-up.
Procedure: Blood Draws

Healthy Participants: Blood (about 2 tablespoons) drawn at 1 time point.

Rectal Cancer Participants: Blood (about 2 tablespoons) drawn 1 time before participant starts treatment.

Blood also drawn:

Just before tumor surgery 1-8 weeks after surgery, or before chemotherapy begins 1-12 weeks after last dose of chemotherapy

  1. year after surgery, OR 1 year after completion of treatment if no surgery
  2. years after surgery, OR 2 years after completion of treatment if no surgery If the disease gets worse during treatment, OR If disease comes back within 6 years after treatment, OR at end of 6 years follow-up.
Other Names:
  • Blood collection
  • Blood Sample




Primary Outcome Measures :
  1. Change in Circulating Tumor Cell (CTC) Status [ Time Frame: 8 weeks after surgery or before chemotherapy ]
    Change in CTC status between Time 1 and 2 described as a No-No; Yes-Yes; Yes->No; No->Yes, where No=no detectable CTC and Yes=detectable CTC.


Biospecimen Retention:   Samples With DNA
Blood (about 2 tablespoons) collected to study the level of circulating tumor cells (CTCs),


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Healthy participants recruited from UT MD Anderson Cancer Clinics (MDACC), and may include MDACC staff.

Rectal cancer participants recruited from UT MD Anderson Cancer gastrointestinal (GI) clinics and MDACC Colorectal Care Centers.

Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02874885


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

Locations
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United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Research Foundation of the American Society of Colon and Rectal Surgeons
Investigators
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Principal Investigator: Yi-Qian N. You, MD M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02874885     History of Changes
Other Study ID Numbers: PA13-0547
First Posted: August 22, 2016    Key Record Dates
Last Update Posted: May 29, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Locally-advanced rectal cancer
LARC
Colorectal cancer
CRC
Rectosigmoid cancer
No known diagnosis of colorectal cancer
Blood draws
Blood samples
Circulating tumor cells (CTC)
CTC

Additional relevant MeSH terms:
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Rectal Neoplasms
Neoplastic Cells, Circulating
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes