Background:
A person s genome is the collection of all their genes. A gene instructs individual cells to make proteins. Proteins are involved in all of our body s chemical processes. Genome sequencing allows researchers to find variations in genes. Some of these are normal and are not known to cause disease. Some variants are known to cause or affect diseases like cancer. Researchers want to study genetic variants in people with cancer who also have an immunologic disease like HIV.
Objective:
To study the biology of cancer in order to improve ways to prevent, detect, and treat it.
Eligibility:
Adults at least 18 years old with certain cancers and/or immunodeficiencies
Design:
Participants will be screened with medical history, physical exam, and lab tests.
Participants will give samples of one or more tissue type.
They may give blood or urine samples.
Researchers may get samples of tissue when participants have surgery or when the participants are on other protocols in the NCI.
Participants may have a procedure to have tissue samples removed.
Researchers may collect data from participant medical records.
Researchers will compare the genes in a participant s cancer tissue to their normal tissue. They may use the tissue cells to grow new cells in a lab.
Participants may be contacted about the results.
The samples will be stored for future research. No personal data will be kept with them.
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Condition or disease |
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Human Immunodeficiency Virus Castleman's Disease Kaposi's Sarcoma Viral-Associated Cancer |
Background:
Objective:
-The primary objective of this protocol is to support molecular investigation of viral associated malignancies, malignancies occurring in the setting of HIV or other immunodeficiencies, and Castleman disease, by accrual of high quality, clinically annotated tissue from such patients as well as patients with tumors that may serve as appropriate controls.
Eligibility:
Design:
Study Type : | Observational |
Estimated Enrollment : | 230 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Molecular Characterization of Viral-associated Tumors, Tumors Occurring in the Setting of HIV or Other Immune Disorders and Castleman Disease |
Actual Study Start Date : | December 20, 2017 |
Estimated Primary Completion Date : | June 7, 2037 |
Estimated Study Completion Date : | June 25, 2037 |
Group/Cohort |
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Group 1
Viral-assoc. cancer; HIV-neg pts with cancer that occurs in HIV pos; KSHV-assoc. cancer or related diseases e.g. multicentric Castleman disease; retrovirus-induced cancer; Idiopathic Castleman disease.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Patients with one or more of the following:
Cancer diagnoses will be confirmed by the NCI Laboratory of Pathology. A biopsy will be collected if sufficient archival tissue is not available.
EXCLUSION CRITERIA:
Contact: Irene Ekwede, R.N. | (240) 760-6126 | ekwedeib@mail.nih.gov |
United States, Maryland | |
National Institutes of Health Clinical Center | Recruiting |
Bethesda, Maryland, United States, 20892 | |
Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office 888-624-1937 |
Principal Investigator: | Robert Yarchoan, M.D. | National Cancer Institute (NCI) |
Tracking Information | |||||
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First Submitted Date | October 3, 2017 | ||||
First Posted Date | October 4, 2017 | ||||
Last Update Posted Date | March 26, 2021 | ||||
Actual Study Start Date | December 20, 2017 | ||||
Estimated Primary Completion Date | June 7, 2037 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
Tissue collection [ Time Frame: Time of collection ] Molecular data from viral associated malignancies, malignancies occurring in the setting of HIV or other immunodeficiencies, and Castleman disease.
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Original Primary Outcome Measures |
Tissue collection [ Time Frame: Time of collection ] | ||||
Change History | |||||
Current Secondary Outcome Measures | Not Provided | ||||
Original Secondary Outcome Measures | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | Molecular Characterization of Viral-associated Tumors, Tumors Occurring in the Setting of HIV or Other Immune Disorders and Castleman Disease | ||||
Official Title | Molecular Characterization of Viral-associated Tumors, Tumors Occurring in the Setting of HIV or Other Immune Disorders and Castleman Disease | ||||
Brief Summary |
Background: A person s genome is the collection of all their genes. A gene instructs individual cells to make proteins. Proteins are involved in all of our body s chemical processes. Genome sequencing allows researchers to find variations in genes. Some of these are normal and are not known to cause disease. Some variants are known to cause or affect diseases like cancer. Researchers want to study genetic variants in people with cancer who also have an immunologic disease like HIV. Objective: To study the biology of cancer in order to improve ways to prevent, detect, and treat it. Eligibility: Adults at least 18 years old with certain cancers and/or immunodeficiencies Design: Participants will be screened with medical history, physical exam, and lab tests. Participants will give samples of one or more tissue type. They may give blood or urine samples. Researchers may get samples of tissue when participants have surgery or when the participants are on other protocols in the NCI. Participants may have a procedure to have tissue samples removed. Researchers may collect data from participant medical records. Researchers will compare the genes in a participant s cancer tissue to their normal tissue. They may use the tissue cells to grow new cells in a lab. Participants may be contacted about the results. The samples will be stored for future research. No personal data will be kept with them. ... |
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Detailed Description |
Background:
Objective: -The primary objective of this protocol is to support molecular investigation of viral associated malignancies, malignancies occurring in the setting of HIV or other immunodeficiencies, and Castleman disease, by accrual of high quality, clinically annotated tissue from such patients as well as patients with tumors that may serve as appropriate controls. Eligibility:
Design:
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Study Type | Observational | ||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Not Provided | ||||
Sampling Method | Non-Probability Sample | ||||
Study Population | The study population will be patients referred by HIV providers and those who provide primary care to the African immigrant community. | ||||
Condition |
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Intervention | Not Provided | ||||
Study Groups/Cohorts | Group 1
Viral-assoc. cancer; HIV-neg pts with cancer that occurs in HIV pos; KSHV-assoc. cancer or related diseases e.g. multicentric Castleman disease; retrovirus-induced cancer; Idiopathic Castleman disease.
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Recruiting | ||||
Estimated Enrollment |
230 | ||||
Original Estimated Enrollment | Same as current | ||||
Estimated Study Completion Date | June 25, 2037 | ||||
Estimated Primary Completion Date | June 7, 2037 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria |
Patients with one or more of the following:
Cancer diagnoses will be confirmed by the NCI Laboratory of Pathology. A biopsy will be collected if sufficient archival tissue is not available.
EXCLUSION CRITERIA:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts |
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Listed Location Countries | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT03300830 | ||||
Other Study ID Numbers | 170174 17-C-0174 |
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Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement | Not Provided | ||||
Responsible Party | National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ) | ||||
Study Sponsor | National Cancer Institute (NCI) | ||||
Collaborators | Not Provided | ||||
Investigators |
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PRS Account | National Institutes of Health Clinical Center (CC) | ||||
Verification Date | March 23, 2021 |