Houston, Texas 77030


Purpose:

The goal of this registry research study is to collect clinical information about every child and young adult in North America diagnosed with cancer and other conditions that are characterized by abnormal cell growth but are benign (not cancer). This information can then be used by researchers to answer questions such as whether childhood cancer is increasing across North America, and whether there is a higher risk of cancer among some groups compared to others. The information can also help researchers study the causes of childhood cancer. Some future studies will involve contact with you, and some studies do not. Objectives: 1. To obtain informed consent from parents of infants, children, adolescents, and young adults newly diagnosed with cancer (and their child when appropriate) to enter their names and certain information concerning their child, including: their name, postal/zip code, e-mail address (requested but not required) social security number (SSN), or Canadian social insurance number (SIN) (SSN/SIN are requested not required) date of birth, diagnosis, diagnosis date, institution, race, ethnicity, sex, language spoken in the home, and date of death (if applicable) into the Childhood Cancer Research Network. This is referred to as: Entry in the CCRN with consent but without permission for future contact. 1.1 {For children under the age of majority at the time of parental consent:} Once the child reaches the age of majority, to obtain informed consent from that child to allow her/his name and other identifying information to continue to be available to the Childhood Cancer Research Network. 2. To obtain informed consent from parents of infants, children, adolescents, and young adults newly diagnosed with cancer (and the child when appropriate) for permission to be possibly contacted in the future to consider participating in non-therapeutic and prevention research studies involving the parents and/or the child. This consent includes the information collected in 1.1 (must include parent's and child's name) along with current address and telephone number. This is referred to as: Entry in the CCRN with consent including permission for future contact. 2.1{For children under the age of majority at the time of parental consent for future contact:} Once the child reaches the age of majority, to obtain informed consent for permission to be possibly contacted in the future to consider participating in non-therapeutic and prevention research studies. This consent includes the information collected in 1.1.2 (must include name) along with current address and telephone number.


Study summary:

The COG has established a research network, known as the Childhood Cancer Research Network (CCRN), for collecting information about children and young adults with cancer and other conditions that are characterized by abnormal cell growth but are benign (not cancer). The CCRN provides information that helps doctors and scientists better understand childhood cancer. Information Collection: If you agree to take part in this registry study, the following information will be sent from your hospital to the CCRN: - Your name - Your parent's/guardian's name(s), if you are under 18 years of age - Your birth date - Your postal/zip code - The type and characteristics of your disease - The date the disease was diagnosed - The COG institution where you are being treated - Your sex (whether you are male or female) - Your race and ethnicity - Language spoken in the home Also, the diagnostic laboratory report that provides specific information about your tumor will also be sent to the CCRN. This additional information is used to study how your geographic location (where you live) affects your risk for different types of cancer. Information Protection: All information about you will be held in strict confidence. Your information will be marked with a unique identification number instead of your name or other identifiable information. This will help to lower the chance that your identifying information is released. The only people who will be able to see identifying information about you are: - staff workers directly involved in running the CCRN - government workers who regulate or conduct oversight over the work of COG and/or the CCRN - researchers and their staff who direct and conduct CCRN-approved research studies These people will all have signed agreements that they will not release any identifying information about CCRN participants. At all times, the information about you will be treated with a high level of confidentiality and will not be made available to anyone other than those listed above, without your permission. Other researchers using your data will not be able to link this data to you, unless you agree to allowing future contact. If at any time you change your mind about having your name (and/or parent or guardian's name) or any other information available in the CCRN, just contact MD Anderson at 713-792-6620. At that time, access to your name (and/or parent or guardian's name) and other identifying information in the CCRN will be restricted. CCRN researchers will no longer have access to your identity or any other information. You might still receive information for studies conducted by researchers not related to the CCRN. Reconsenting after age of majority: If you are under 18 years of age now, your parent/guardian must sign this informed consent before your name and any other information can be entered in CCRN. When you reach the age of majority, (and if your parent or guardian agreed to allow your contact information to be collected in CCRN), M.D Anderson researchers will contact you and ask that you continue to participate in this study. If you agree to continue to participate, you will sign this informed consent and your name and any other information will remain in CCRN. If you refuse to continue to participate, after the age of majority, access to your name and other identifying information in the CCRN will be restricted, but your parent's/guardian's name will remain in CCRN. Your parent/guardian might receive information for studies performed by researchers not related to CCRN. Certificate of Confidentiality: The COG has received a Certificate of Confidentiality from the federal government, which will help them to protect the privacy of their research participants. The Certificate protects against the involuntary release of information about participants collected during the course of their covered studies. The researchers involved in the studies cannot be forced to disclose the identity or any information collected in the study in any legal proceedings at the federal, state, or local level, regardless of whether they are criminal, administrative, or legislative proceedings. However, the participants or the researcher may choose to voluntarily disclose the protected information under certain circumstances. For example, if the participants or their guardians request the release of information in writing, the Certificate does not protect against that voluntary disclosure. Furthermore, federal agencies may review the COG's records under limited circumstances, such as a DHHS request for information for an audit or program evaluation or an FDA request under the Food, Drug, and Cosmetics Act. This is an investigational study.


Criteria:

Inclusion Criteria: 1. All patients, diagnosed with a primary malignancy since the date the initial IRB approval was received for this study with any of the following diagnoses are eligible: 2. a. All cancer cases with an ICD-O histologic behavior code of two "2" (carcinoma in situ) or three "3" (malignant); 3. b. All lesions of the central nervous system regardless of behavior, i.e., benign, borderline or malignant; 4. c. The benign/borderline conditions which will be reportable by agreement shall include: Mesoblastic nephroma, All teratomas, regardless of locations, Myeloproliferative disease, Langerhan's Cell histiocytosis; 5. d. Patients with a secondary malignancy may be eligible provided they also meet the criteria in 1). These patients need to be enrolled using their primary diagnosis. 6. Participants 0 through 21 years of age are eligible; irrespective of eligibility for other COG studies. 7. Participant must be a resident of the United States, Canada or Mexico. 8. Approval for the use of this protocol by the local Institutional Review Board or equivalent must be obtained, in accordance with institutional assurance policies of the U.S. Department of Health and Human Services and the Canadian Tri-Council Report of the Medical Research Council of Canada. 9. All patients and/or their parents or legal guardians must sign a written informed consent. 10. PHI Authorization:The local institution must provide verification that authorization to release PHI was obtained. With this authorization a unique patient number (UPN) will be assigned, which will be used as the COG patient ID number. Exclusion Criteria: 1. Any patient who refuses a written informed consent. 2. Patients >21 years of age. 3. Patients that are not residents of United States, Canada or Mexico.


NCT ID:

NCT00799253


Primary Contact:

Principal Investigator
Najat Daw-Bitar, MD
UT MD Anderson Cancer Center

Najat Daw-Bitar, MD
Phone: 713-792-6620


Backup Contact:

N/A


Location Contact:

Houston, Texas 77030
United States



There is no listed contact information for this specific location.

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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