NCT01109394 Comprehensive Omics Analysis of Pediatric and Adult Solid Tumors and Establishment of a Repository for Related Biological Studies
| NCT ID | NCT01109394 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Cancer Institute (NCI) |
| Condition | Sarcoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 6,035 participants |
| Start Date | 2010-04-21 |
| Primary Completion | — |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 6,035 participants in total. It began in 2010-04-21.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Background: \- Laboratory investigators who are studying common childhood cancers are interested in developing a tissue repository to collect and store blood, serum, tissue, urine, or tumors of children who have cancer or adults who have common childhood cancers. To develop this repository, additional samples will be collected from children and adults who have been diagnosed with common childhood cancers such as leukemia and tumors of the central nervous system. Objectives: \- To collect and store blood, serum, tissue, urine, or tumor samples of children who have cancer or adults who have common childhood cancers. Eligibility: * Individuals who have been diagnosed with a common childhood cancer (e.g., leukemia) regardless of patient age. * Children, adolescents, and adults who have been diagnosed with a type of cancer more commonly found in adults. Design: * Extra blood, serum (the liquid part of blood), tissue, urine, or tumor samples will be collected from participants at a time when sampling is required for medical care or as part of a research study. * No additional procedures will be performed for the sole purpose of obtaining additional tumor tissue, aside from what is required for clinical care.
Eligibility Criteria
* SUBJECT INCLUSION CRITERIA: Pediatric or adult subjects with one of the following: * Diagnosis of any tumor, malignancy, pre-malignant disorder, or suspected premalignant familial syndromes, regardless, of patient age; * Biological relatives of any patient with a tumor, malignancy, pre-malignant disorder, or suspected familial pre-malignant syndrome, regardless of patient age or the diagnosis of an adult malignancy or pre-malignant disorder; * Healthy Volunteer without history of malignancy nor a family member currently being treated for cancer who are undergoing surgery, treatment or during well visits; * Biospecimens can be collected with minimal additional risk to the subject during sampling or procedures required for routine patient care. * Human samples, specimens and data collected on IRB approved protocols that are now closed * Ability of subject, Legally Authorized Representative (LAR), or parent/legal guardian of children \<=18 to understand and be willing to sign an IRB-approved informed consent document that permits the use of the tumor and other samples for genomic-based molecular characterization projects. Inclusion Criteria for Social and Behavioral Outcome Interviews: * Parent/caregiver of a participating pediatric or adult patient who is being treated for, or who has previously been treated for any form of pediatric cancer. * Must be able to give consent and sign the informed consent document. * Able to understand the English language. EXCLUSION CRITERIA: None
Contact & Investigator
Rosandra N Kaplan, M.D.
PRINCIPAL INVESTIGATOR
National Cancer Institute (NCI)
Frequently Asked Questions
Who can join the NCT01109394 clinical trial?
This trial is open to participants of all sexes, aged 4 Weeks or older, studying Sarcoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT01109394 currently recruiting?
Yes, NCT01109394 is actively recruiting participants. Contact the research team at bernsted@mail.nih.gov for enrollment information.
Where is the NCT01109394 trial being conducted?
This trial is being conducted at Washington D.C., United States, Orange, United States, Bethesda, United States, New York, United States and 1 additional location.
Who is sponsoring the NCT01109394 clinical trial?
NCT01109394 is sponsored by National Cancer Institute (NCI). The principal investigator is Rosandra N Kaplan, M.D. at National Cancer Institute (NCI). The trial plans to enroll 6,035 participants.