The Project: Every Child Protocol: A Registry Eligibility Screening Biology and Outcome Study
S
Sandeep Batra, MD
Primary Investigator
Enrolling By Invitation
1-25 years
All
Phase
N/A
2 Locations
Brief description of study
What is the purpose of this study?
This study gathers health information for the Project: Every Child for
younger patients with cancer.
Gathering health information over time from younger patients with cancer
may help doctors find better methods of treatment and on-going care.
THIS STUDY IS ENROLLING BY INVITATION ONLY - Consistent with most oncology trials, patients are not actively “recruited,” but are screened by their physician for appropriate clinical trial(s) at the time of their routine clinic visit. Occasionally, a patient may be a self-referral or physician referral, but are still screened for appropriate clinical trials at the time of their routine clinic visit. PI and staff may send copies of relevant consent forms to these patients to look over prior to actually consenting or enrolling them. This may take place at the patient's visit at which the consent is presented or the patient's next visit to the outpatient hematology/oncology clinic.
Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office
Email: iutrials@iu.edu
Phone: (317) 278-5632
Detailed description of study
What will happen during the study?
- Patients undergo medical data review to create a Childhood Cancer Registry.
- Patients also undergo collection of biospecimen samples (e.g., tissue, blood, bone marrow, plasma, serum, buccal swab, saliva, cerebrospinal fluid, or urine).
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Riley, Central Nervous System Neoplasm,Childhood Lymphoma,Childhood Relapsed Solid Tumor
-
Age: Between 1 Year - 25 Years
-
Gender: All
Inclusion Criteria
- Enrollment must occur within 6 months of initial disease presentation OR within 6 months of refractory disease, disease progression, disease recurrence, second or secondary malignancy, or post-mortem
- Patients previously enrolled on ACCRN07 are eligible to enroll on Tracking Outcome, Registry and Future Contact components of APEC14B1 any time after they reach age of majority
- Patients with a known or suspected neoplasm that occurs in the pediatric, adolescent or young adult populations are eligible for enrollment as follows:
- All cancer cases with an International Classification of Diseases for Oncology (ICD-O) histologic behavior code of one "1" (borderline), two "2" (carcinoma in situ) or three "3" (malignant)
- All neoplastic lesions of the central nervous system regardless of behavior, i.e., benign, borderline or malignant
- The following other benign/borderline conditions:
- Mesoblastic nephroma
- Teratomas (mature and immature types)
- Myeloproliferative diseases including transient myeloproliferative disease
- Langerhans cell histiocytosis
- Lymphoproliferative diseases
- Desmoid tumors
- Gonadal stromal cell tumors
- Neuroendocrine tumors including pheochromocytoma
- Melanocytic tumors, except clearly benign nevi
- Ganglioneuromas
- Subjects must be =< 25 years of age at time of original diagnosis, except for patients who are being screened specifically for eligibility onto a COG (or COG participating National Clinical Trials Network [NCTN]) therapeutic study, for which there is a higher upper age limit
- All patients or their parents or legally authorized representatives must sign a written informed consent and agree to participate in at least one component of the study; parents will be asked to sign a separate consent for their own biospecimen submission
- If patients or their parents or legally authorized representatives have not signed the Part A subject consent form at the time of a diagnostic bone marrow procedure, it is recommended that they initially provide consent for drawing extra bone marrow using the Consent for Collection of Additional Bone Marrow; consent using the Part A subject consent form must be provided prior to any other procedures for eligibility screening or banking under APEC14B1
Updated on
12 Sep 2024.
Study ID: PHO-COG-FALLON-APEC14B1, 1511914729
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