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 @ 2:22 AM
Ignite Modification Date:
2025-12-25 @ 2:22 AM
NCT ID:
NCT02713334
Eligibility Criteria:
Inclusion Criteria:
Patients (Phase I):
* 18 years of age or older
* Has consented to MSK IRB protocol #12-245, Consent A and Part C
* Has not received secondary findings as a result of MSK IRB protocol #12-245, Consent Part C as per EMR and/or patient report
* Diagnosed with a solid tumor as per EMR and/or clinician judgment
* English-fluent; the surveys were designed and validated in English and are not currently available in other languages. Translation of questionnaires into other languages would require reestablishing the reliability and validity of these measures. Therefore, participants must be able to communicate in English to complete the surveys.
Family members (Phase I):
* 18 years of age or older as per self report
* Nominated by the patient participant as a family member with whom the secondary findings have been shared (spouses/partners are eligible as "family members" for the purposes of this study)
* English-fluent; the surveys were designed and validated in English and are not currently available in other languages. Translation of questionnaires into other languages would require reestablishing the reliability and validity of these measures. Therefore, participants must be able to communicate in English to complete the surveys.
Patients (Phase 2):
* 18 years of age of older
* Has consented to MSK IRB protocol #12-245, Consent Part A and C
* English-fluent; the surveys were designed and validated in English and are not currently available in other languages. Translation of questionnaires into other languages would require reestablishing the reliability and validity of these measures. Therefor, participants must be able to communicate in English to complete the surveys.
AYA Survivors of Pediatric Cancers (Phase 3):
* Age 15 to 30 years old
* Are at least 1 year post-treatment for pediatric cancer (i.e., any cancer diagnosed before age 18)
* Has consented or provided assent to MSK IRB protocol #12-245, Consent Part A and C
* Has received pathogenic secondary findings as a result of MSK IRB protocol #12- 245, Consent Part C as per EMR and/or CGS care provider report
* Participated in a CGS consultation following receipt of secondary findings
* English-fluent; the surveys were designed and validated in English and are not currently available in other languages. Translation of questionnaires into other languages would require reestablishing the reliability and validity of these measures. Therefore, participants must be able to communicate in English to complete the surveys.
Adult Caregivers of Survivors of Pediatric Cancers (Phase 3):
* 18 years of age or older
* Are the caregiver of a child who was treated for pediatric cancer (i.e., any cancer diagnosed before age 18). Caregiver status is based on either: 1) nomination as such by a young adult survivor (i.e., age 18+), 2) having consented on behalf of a minor child (i.e., age \<18) to MSK IRB protocol
#12-245 Part A and C plus self-reported confirmation that s/he is the caregiver for the child, or 3) nomination by the adult who consented on behalf of a minor child (i.e., age \<18) to MSK IRB protocol #12-245 Part A and C plus self-reported confirmation that s/he is the caregiver for the child
* That child is currently alive and at least 1 year post-treatment for pediatric cancer (i.e., any cancer diagnosed before age 18)
* Has consented on behalf of that child, or that child consented, to MSK IRB protocol #12-245, Consent Part A and C
* That child received pathogenic secondary findings as a result of MSK IRB protocol #12-245, Consent Part C as per EMR and/or CGS healthcare provider report
* Participated in a CGS consultation following receipt of secondary findings
* English-fluent; the surveys were designed and validated in English and are not currently available in other languages. Translation of questionnaires into other languages would require reestablishing the reliability and validity of these measures. Therefore, participants must be able to communicate in English to complete the surveys
Exclusion Criteria:
* Received genetic testing in the past that resulted in a pathogenic finding or a variant of unknown significance as reported in the EMR.
* Major psychiatric illness or cognitive impairment that in the judgment of the investigator or study staff would preclude study participation
* Any patients who are unable to comply with the study procedures as determined by the study investigators or study staff.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02713334
Study Brief:
Protocol Section:
NCT02713334