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 @ 2:09 AM
Ignite Modification Date:
2025-12-25 @ 2:09 AM
NCT ID:
NCT02732860
Eligibility Criteria:
Inclusion Criteria:
1. Age \> 18 years.
2. Patient diagnosis must be categorized as either (I) OR (II) OR (III) OR (IV):
(I) Histologically confirmed Triple Negative Breast Cancer by Institutional and American Society of Clinical Oncology (ASCO)/Cancer of American Pathologists (CAP) guidelines, either:
* Stage IV (metastatic) disease that has not been treated with systemic therapy in the metastatic setting or
* Stage I to III (non-metastatic) with residual mass by clinical exam and/or breast imaging following anthracycline + taxane-containing neoadjuvant chemotherapy
OR
(II) Histologically-confirmed Stage IV colorectal cancer treated with ≤ 1 line of systemic therapy in the metastatic setting, either:
* Undergoing surgical resection of liver metastases or
* With metastatic lesions amenable to biopsy
OR
(III) Histologically-confirmed advanced High Grade Serous Ovarian Cancer, either:
* Recurrent disease with a life expectancy of at least 12 months or
* Stage III or IV with residual disease following neoadjuvant chemotherapy, or at risk of high recurrence
OR
(IV) Histologically confirmed solid tumor not meeting criteria for (I), (II) or (III) above, for which evaluation of investigational therapies is of particular interest or where clinical need exists, at the discretion of the PI
3. Disease amenable to biopsy or surgery for tissue procurement
4. Eastern Cooperative Oncology Group (ECOG) performance status 0-1
5. Willingness and ability of patient to provide signed voluntary informed consent.
Exclusion Criteria:
1. Clinically significant hepatic, renal, cardiac or other organ dysfunction likely to limit participation in clinical trials.
2. Known brain metastasis
3. Any condition that could interfere with a patient's ability to provide informed consent such as dementia or severe cognitive impairment.
4. Any contraindication to undergoing a biopsy procedure.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02732860
Study Brief:
Protocol Section:
NCT02732860