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:
2025-12-24 @ 5:36 PM
Ignite Modification Date:
2025-12-24 @ 5:36 PM
NCT ID:
NCT04589468
Eligibility Criteria:
Inclusion Criteria:
* Postsurgical diagnosis of patients with primary solid tumors at high-risk of relapse as defined by one of the following:
° High-risk primary solid tumor (e.g., colorectal, ovarian, non-small cell lung cancer) (colorectal cancer only for Phase 1a)
* Stage 3 or
* ctDNA positive
° High-risk breast cancer
* Residual invasive disease in the breast or the lymph nodes following completion of neoadjuvant chemotherapy (NACT),
* Estrogen receptor (ER), and/or progesterone receptor (PR) positive and HER2 negative,
* CPS-EG score ≥ 3,
* CPS-EG score ≥2 w ith ypN+, or
* Recurrence score ≥ 25
* No evidence of disease
* Age ≥ 18
* Interval of ≥ 1 month but ≤ 2 years following completion of all definitive adjuvant therapy
* Non-exercising (i.e., \< 30 minutes of moderate and \< 20 mins of vigorous exercise/wk), as assessed by remote activity and heart rate tracking for a 7-day period prior to study entry)
° If ≥ 30 minutes but less than 45 minutes of moderate exercise/week, or if ≥ 20 minutes but less than 30 minutes of vigorous exercise/week, patients may be eligible, at the discretion of the PI.
* Cleared for exercise participation as per screening clearance via PAR-Q+
* Willingness to comply with all study-related procedures
Exclusion Criteria:
* Enrollment onto any other interventional investigational study except interventions determined by the PI not to confound study outcomes
* Any other current diagnosis of invasive cancer of any kind
* Distant metastatic malignancy of any kind
* Any other condition or intercurrent illness that, in the opinion of the investigator, makes the subject a poor candidate for study participation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04589468
Study Brief:
Protocol Section:
NCT04589468