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 @ 11:05 PM
Ignite Modification Date:
2025-12-24 @ 11:05 PM
NCT ID:
NCT02315469
Eligibility Criteria:
Inclusion Criteria:
* Patients with suspected ovarian, fallopian tube, primary peritoneal carcinomas or advanced stage papillary serous uterine carcinoma irrespective of performance status; this clinical determination is made by the treating physician
* Patients must have signed an approved informed consent and authorization permitting release of personal health information
* Patients who can understand sufficiently to be able to respond to questions posed by the study instruments
* Patients and/or caregiver (durable power of attorney) can give consent and caregiver can assist with the responses to questionnaire
* NOTE: it is the intent of this trial that all patients 70 years or older presenting to the participating physician/center be offered enrollment onto this study; eligible patients may enroll and subsequently receive neoadjuvant chemotherapy followed by interval surgery, primary cytoreductive surgery or no surgery at all
* Post-operative pathology will not exclude patients from this study
Exclusion Criteria:
* Patients whose circumstances at the time of study entry do not permit completion of the study or required follow-up
* Patients who would have planned surgery performed by the minimally invasive technique; institutions which perform cytoreductive surgery via the minimally invasive technique should not participate in this study; the minimally invasive surgery (MIS) technique is also not considered standard technique for primary cytoreductive surgery for advanced stage ovarian, fallopian tube or peritoneal cancers
* Patients who receive chemotherapy treatment (for a gynecologic malignancy) prior to consideration of enrollment into this trial and taking the geriatric assessment will be excluded
* Patients who have a known pre-operative primary uterine cancer, confirmed by endometrial biopsy
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
70 Years
Study:
NCT02315469
Study Brief:
Protocol Section:
NCT02315469