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 @ 2:41 AM
Ignite Modification Date:
2025-12-25 @ 2:41 AM
NCT ID:
NCT04330833
Eligibility Criteria:
Inclusion Criteria:
* Child 1 month to \< 18 years
* Child newly diagnosed, i.e., within 16 weeks (112 days) from time of diagnosis of cancer not including the day of diagnosis, OR
* Child with relapsed cancer, defined as within 16 weeks (112 days) of first-time relapse/evidence of progression of disease as noted by scan or biopsy after previous diagnosis of cancer.
* Child provide assent if age ≥ 7 years
* Poor prognosis, i.e., approximate \< 25 % estimated overall survival or at the discretion of the attending AND/OR:
* Falls into one of the following diagnosis categories, including but not limited to:
* Atypical teratoid rhabdoid tumor
* Glioblastoma multiforme
* Diffuse intrinsic brainstem glioma
* Embryonal tumors with multilayered rosettes
* Other high-grade glioma
* Gliomatosis cerebri
* Metastatic osteosarcoma
* Metastatic Ewing sarcoma
* Metastatic rhabdomyosarcoma
* Metastatic desmoplastic small round cell tumor (DSRCT)
* Other metastatic sarcoma/carcinoma-at discretion of attending
* Metastatic unknown primary- or rare pathology- at discretion of attending
* Parent(s) legal decision-maker(s) for child
* Parent(s) ≥18 years of age
* Parent (s) Informed of child's cancer diagnosis
* Parent(s) Able to read, speak and understand English
* Must be willing to be audio recorded during all study sessions.
Exclusion Criteria:
* The parent has neurological/cognitive impairments likely to interfere with study participation;
* The child ≥ 7 years of age does not provide assent
* Parent refuses to be audio recorded during sessions.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Month
Maximum Age:
17 Years
Study:
NCT04330833
Study Brief:
Protocol Section:
NCT04330833