Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2025-12-25 @ 3:53 AM
NCT ID:
NCT04264702
Eligibility Criteria:
Inclusion criteria:
1. 18 years of age or older.
2. Planning or undergone surgical resection of adenocarcinoma of the colon or rectum.
3. Diagnosis of Colorectal cancer that falls into one of the below categories:
1. Stage I to IV disease.
2. Stage IV with oligometastatic disease eligible for post-operative systemic therapy.
4. Selected by their healthcare provider to receive the SIGNATERA™ test according to the current evidence-informed schedule as part of their routine practice.
5. ECOG performance status ≤ 2
6. Clinically eligible for post-operative systemic therapy.
7. Able to tolerate venipuncture for research blood draw(s).
8. Able to read, understand and provide written informed consent .
9. Willing and able to comply with the study requirements.
Exclusion Criteria:
1. Pregnant or breastfeeding.
2. Prior history and treatment for any cancer within the past year or has another active cancer, with the exception of non-melanoma skin cancer
3. Has a known rare inherited genetic condition, with the exception of lynch syndrome
4. Has initiated post-operative systemic therapy.
5. Neuropathy \> grade 2.
6. History of bone marrow or organ transplant.
7. Medical condition that would place the patient at risk as a result of blood donation, such as bleeding disorder .
8. Serious medical condition that may adversely affect ability to participate in the study.
Control Arm Inclusion criteria:
1. 18 years of age or older at time of diagnosis.
2. Diagnosis of Colorectal cancer that falls into one of the below categories:
1. Stage I to IV disease.
2. Stage IV with oligometastatic disease eligible for post-operative systemic therapy.
3. Were clinically eligible for chemotherapy at full recommended doses per Health Care Provider.
4. Received treatment no more than 3 years prior to study start date.
5. Have a minimum of least 2 years clinical follow-up data or reached a progression event.
Control Arm Exclusion criteria:
1. Female patients that were pregnant or breastfeeding during historical control collection period.
2. Per investigator, was not clinically eligible for post-operative systemic therapy.
3. Had an ECOG performance status ≤ 2 at time of diagnosis.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04264702
Study Brief:
Protocol Section:
NCT04264702