Cancer Clinical Trial
Official title:
Effect of SNPs in p53 and p53 Response Elements on the Inflammatory Response to DNA Damage
NCT number | NCT01143519 |
Other study ID # | 100134 |
Secondary ID | 10-E-0134 |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 21, 2012 |
Verified date | June 14, 2024 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Background: - Research has shown that certain proteins in cells may be linked to higher risks of developing inflammations, tumors, and other medical problems. By examining how the blood cells of healthy volunteers respond to environmental exposures, researchers hope to better understand the relationship of genes, environmental factors, and human diseases. Objectives: - To examine how specific genes and proteins in blood cells respond to environmental exposures. Eligibility: - Healthy volunteers between 18 and 45 years of age. Design: - The study will involve one visit of 45 to 60 minutes. - Participants will be screened with a brief physical examination and finger stick to determine if they are eligible to donate blood for the study, and will complete a questionnaire about any medications or other drugs (e.g., cigarettes) they may be taking. - Participants will provide a blood sample for research purposes.
Status | Completed |
Enrollment | 178 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | - INCLUSION CRITERIA: - Male or female 18 years of age or older - Participants must be able to understand and provide written informed consent to participate in the study - Participants must be able to travel to the CRU - Nonpregnant - Healthy participants as defined by the International Red Cross guidelines (Healthy means that an individual feels well and can perform normal activities. If the individual has a chronic condition such as diabetes or high blood pressure, healthy also means that they are being treated and the condition is under control). - Participants with health outcomes identified by genotype-phenotype association studies. - HIV-1 seropositive under medicament treatment (for HIV P53 and TLR8 groups only) (checked every 6 months at visit) EXCLUSION CRITERIA: - Use of immunosuppressants or other immune-modifying drugs [e.g., Rituxan, Humira, Enbrel, Cyclosporin (Neoral, Sandimmune, and SangCya), Azathioprine (Imuran)], Monoclonal antibodies [e.g., infliximab (Remicade)] (for healthy controls only) - Chronic use of systemic, inhaled steroids - Current or use of prescription strength topical corticosteroids within the last 7days - History of cancer, including skin cancer (for healthy controls only) - History of chemotherapy or radiation treatment (for healthy controls only) - Confirmed or suspected immunosuppressive or immunodeficient condition (for healthy controls only) - Hepatitis B/C-positive status (checked every 6 months at visit) - Body weight < 50 kg (<110 lbs) - If blood donation exceeds 200ml: --Hematocrit <34% for women or <36% for men, or >56% for either gender - Temperature > 37.6 C; blood pressure < 90/50 mm Hg or blood pressure >160/100 mm Hg; pulse rate < 50 or > 100 beats/minute - Blood or plasma donation that will cause the participant to exceed 550ml of blood in the last 8 weeks - HIV1 donors with opportunistic infections: - Candidiasis of bronchi, trachea, esophagus, or lungs - Invasive cervical cancer - Coccidioidomycosis - Cryptococcosis - Cryptosporidiosis, chronic intestinal (greater than 1 month's duration) - Cytomegalovirus disease (particularly CMV retinitis) - Encephalopathy, HIV-related - Herpes simplex: chronic ulcer(s) (greater than 1 month's duration); or bronchitis, pneumonitis, or esophagitis - Histoplasmosis - Isosporiasis, chronic intestinal (greater than 1 month's duration) - Kaposi's sarcoma - Lymphoma, multiple forms - Mycobacterium avium complex - Tuberculosis - Pneumocystis carinii pneumonia - Pneumonia, recurrent - Progressive multifocal leukoencephalopathy - Salmonella septicemia, recurrent - Toxoplasmosis of brain - Wasting syndrome due to HIV - HIV and hepatitis results will be confidentially obtained. Testing will be contracted to an external certified laboratory. Results will be available only to the study team, with the few caveats that follow: All positive HIV, hepatitis B, and hepatitis C results that are unexpected (i.e. participant is not currently enrolled in the EPR as an HIV-1 seropositive under medicament treatment) will be promptly communicated to the donor by the study doctor/PI or the CRU Director. The participant will be referred to their physician and/or to the N.C. Department of Health for confirmatory testing and counseling. As explained in detail in the attached Supplement describing N.C. State Department of Health code will be followed. The state code mandates reporting of positive results along with the participant s name and identifying information to the N.C. Department of Public Health. Upon contracting with the testing laboratory, clarification will be obtained and documented as to whether the contracted laboratory or the study MD will be responsible for reporting positive results to the state to avoid duplication of reporting. Upon receipt of the test results, the N.C. Department of Health will contact the participant to inform them of the positive result, how to find care, how to avoid infecting others, how the newly diagnosed HIV and/or hepatitis infection is reported, and the importance of informing their partners at possible risk because of their HIV and/or hepatitis infection. If the HIV, hepatitis B, and hepatitis C results are negative, the participant will be not be notified. However, the participant may contact the research study nurse for their results. HIV and hepatitis B/C test results, non-reactive and reactive, will be documented confidentially by the PI or study coordinator in the subject s file, and kept in a locked file cabinet in the CRU Medical Records Room. In order to document the reporting procedure and the time associated with the reporting process, a document has been created and placed in the study specific manual (Hepatitis B/C and HIV Notification Process for Reactive Results Form). -Healthy control participants carrying SNPs TLR8 and FLT1 who are currently taking hormonal contraception (e.g. oral contraceptives, IUDs with hormones, contraceptive patches) or hormone replacement therapy will be excluded from the study unless the participant has been off of the hormone treatment for 1 month or longer. |
Country | Name | City | State |
---|---|---|---|
United States | NIEHS Clinical Research Unit (CRU) | Research Triangle Park | North Carolina |
Lead Sponsor | Collaborator |
---|---|
National Institute of Environmental Health Sciences (NIEHS) |
United States,
Bond GL, Hu W, Bond EE, Robins H, Lutzker SG, Arva NC, Bargonetti J, Bartel F, Taubert H, Wuerl P, Onel K, Yip L, Hwang SJ, Strong LC, Lozano G, Levine AJ. A single nucleotide polymorphism in the MDM2 promoter attenuates the p53 tumor suppressor pathway and accelerates tumor formation in humans. Cell. 2004 Nov 24;119(5):591-602. doi: 10.1016/j.cell.2004.11.022. — View Citation
Menendez D, Inga A, Resnick MA. The expanding universe of p53 targets. Nat Rev Cancer. 2009 Oct;9(10):724-37. doi: 10.1038/nrc2730. — View Citation
Murphy ME. Polymorphic variants in the p53 pathway. Cell Death Differ. 2006 Jun;13(6):916-20. doi: 10.1038/sj.cdd.4401907. No abstract available. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | p53 target gene expression | The primary endpoint of this study is p53 target gene expression measured by RTPCR for the following five SNPs: p53 rs1042522, MDM2 rs2279744, FLT1 C-677T, TLR8 rs3761624 and RMM1 rs1465952. | analysis on blood drawn at visit | |
Secondary | p53 promoter occupancy | Measured by ChIP analysis for the following SNPs: FLT1 C-677T, TLR8 rs3761624 and RMM1 rs1465952. | analysis on blood drawn at visit |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05346796 -
Survivorship Plan HEalth REcord (SPHERE) Implementation Trial
|
N/A | |
Recruiting |
NCT05094804 -
A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents
|
Phase 1/Phase 2 | |
Completed |
NCT04867850 -
Effect of Behavioral Nudges on Serious Illness Conversation Documentation
|
N/A | |
Enrolling by invitation |
NCT04086251 -
Remote Electronic Patient Monitoring in Oncology Patients
|
N/A | |
Completed |
NCT01285037 -
A Study of LY2801653 in Advanced Cancer
|
Phase 1 | |
Completed |
NCT00680992 -
Study of Denosumab in Subjects With Giant Cell Tumor of Bone
|
Phase 2 | |
Completed |
NCT00062842 -
Study of Irinotecan on a Weekly Schedule in Children
|
Phase 1 | |
Active, not recruiting |
NCT04548063 -
Consent Forms in Cancer Research: Examining the Effect of Length on Readability
|
N/A | |
Completed |
NCT04337203 -
Shared Healthcare Actions and Reflections Electronic Systems in Survivorship
|
N/A | |
Recruiting |
NCT04349293 -
Ex-vivo Evaluation of the Reactivity of the Immune Infiltrate of Cancers to Treatments With Monoclonal Antibodies Targeting the Immunomodulatory Pathways
|
N/A | |
Terminated |
NCT02866851 -
Feasibility Study of Monitoring by Web-application on Cytopenia Related to Chemotherapy
|
N/A | |
Active, not recruiting |
NCT05304988 -
Development and Validation of the EFT for Adolescents With Cancer
|
||
Completed |
NCT04448041 -
CRANE Feasibility Study: Nutritional Intervention for Patients Undergoing Cancer Surgery in Low- and Middle-Income Countries
|
||
Completed |
NCT00340522 -
Childhood Cancer and Plexiform Neurofibroma Tissue Microarray for Molecular Target Screening and Clinical Drug Development
|
||
Recruiting |
NCT04843891 -
Evaluation of PET Probe [64]Cu-Macrin in Cardiovascular Disease, Cancer and Sarcoidosis.
|
Phase 1 | |
Active, not recruiting |
NCT03844048 -
An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial
|
Phase 3 | |
Completed |
NCT03109041 -
Initial Feasibility Study to Treat Resectable Pancreatic Cancer With a Planar LDR Source
|
Phase 1 | |
Completed |
NCT03167372 -
Pilot Comparison of N-of-1 Trials of Light Therapy
|
N/A | |
Terminated |
NCT01441115 -
ECI301 and Radiation for Advanced or Metastatic Cancer
|
Phase 1 | |
Recruiting |
NCT06206785 -
Resting Energy Expenditure in Palliative Cancer Patients
|