Study of the Effect of SNPs in p53 and p53 Response Elements on the Inflammatory Response to DNA Damage

Completed

Conditions studied: HIV-1 Seropositive, Inflammation, Cancer, Cardiomyopathy

In brief

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.

Key facts

Study ID

NCT01143519

Run by

National Institute of Environmental Health Sciences (NIEHS)

People needed

178

Starts

2012-05-21

Last updated by the study team

2026-04-17

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• 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

Where it is running

• NIEHS Clinical Research Unit (CRU) — Research Triangle Park, North Carolina, United States

Full record on ClinicalTrials.gov

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