Comprehensive Omics Analysis of Pediatric and Adult Solid Tumors and Establishment of a Repositor… (NCT01109394) | Clinical Trial Compass
RecruitingNot Applicable
Comprehensive Omics Analysis of Pediatric and Adult Solid Tumors and Establishment of a Repository for Related Biological Studies
United States6,035 participantsStarted 2010-04-21
Plain-language 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.
Who can participate
Age range
4 Weeks
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* 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 CRITERI…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial involves collecting and analyzing tissue samples from my tumor rather than testing a new treatment, what exactly would be done with my sample, and would participating change anything about my current care plan?
2This study covers several different cancer types including sarcoma, neuroblastoma, and renal cancer — can you help me understand whether the omics analysis being done is specifically relevant to my diagnosis, and how that information might or might not benefit me directly?
3Because this is a repository and analysis study rather than a treatment trial, are there any physical risks involved in contributing my tissue sample, or would it use tissue that's already being removed as part of my standard care?
4Could the genomic or molecular findings from this study ever be shared back with me or my care team in a way that might influence future treatment decisions, and if so, how would that process work?
5Are there any privacy considerations I should understand before agreeing to have my biological samples and health information stored in a research repository long-term?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.