A Registry Called Every Child for Collecting Data and Biology Specimens on Younger Patients with Cancer
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 15-008127
NCT ID: NCT02402244
Sponsor Protocol Number: APEC14B1
About this study
The purpose of this registry called Every Child, is to collect data and biospecimens from multiple body sources for younger patients with cancer over time. Gathering health information over time from younger patients with cancer may help doctors find better methods of treatment and on-going care.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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 ICD-O histologic behavior code of 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.
- 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 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.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
Mayo Clinic Location |
Status |
Contact |
Rochester, Minn.
Mayo Clinic principal investigator Wendy Allen-Rhoades, M.D., Ph.D. |
Open for enrollment |
Contact information:
Cancer Center Clinical Trials Referral Office
(855) 776-0015
|
More information
Publications
Publications are currently not available