Breast Cancer Clinical Trial

Wellderly Immune Antibodies Study, a Sub-Study of Healthy Elderly Active Longevity (HEAL) Cohort

Summary

The aim of this sub-study is to determine whether healthy individuals over 90 years of age possess immune cells that are involved in protection from chronic disease. The immune system is well known to produce anti-cancer and other immune cells, called antibodies that can be beneficial to our health. In this study the investigators will evaluate the immune status of the healthy individuals over 90 years of age. The investigators will be focused on studying molecules known to be involved in cholesterol, cancer like those for prostate cancer and breast cancer, inflammatory diseases, and infectious diseases like influenza.

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Full Description

The aim of this sub-study is to determine whether the Wellderly posess neutralizing antibodies targeting antigens involved in chronic disease. The humoral immune system is well known to produce anti-cancer and other antibodies that can be long lived in vivo. In this study we will evaluate the antibody status of the Wellderly with respect to neutralizing (i) molecules known to induce cholesterol like PCSK9, (ii) antibodies against cancer antigens like PMSA (prostate cancer) or Her2 (Breast cancer), (iii) antibodies against inflammatory molecules like TNFa or IL-6, (iv) antibodies that have broad neutralizing activity against infectious diseases like influenza.

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Eligibility Criteria

INCLUSION CRITERIA

Age 90 and over
Gender: Male and Female
Enrolled in the Healthy Elderly (HEAL) study prior to enrollment in this sub-study
Eligible for Blood draw
Be reliable, cooperative and willing to comply with all protocol-specified procedures.
Able to understand and grant informed consent

Be healthy or have mild medical conditions that may be associated with the normal aging process, including:

Hypertension, well controlled with no more than 3 medications
Osteoporosis or Osteopenia
Osteoarthritis
Benign Prostatic Hypertrophy
Cataracts, Glaucoma or Macular Degeneration
Dyslipidemia
Hypothyroidism
Pre-Diabetes/Impaired Fasting Glucose (fasting blood glucose 100-126 mg/dL, if known)
Basal or Squamous Cell Carcinoma

Individuals will be excluded if ANY of the following conditions apply:

EXCLUSION CRITERIA

Less than 90 years of age
Currently undergoing treatment with any investigational agents or devices within 30 preceding enrollment in this study.

Self-reported history or current diagnosis of significant chronic conditions including:

Any Cancer (including polycythemia; excluding basal or squamous cell carcinoma
Coronary Artery Disease, Myocardial Infarction
Stroke or Transient Ischemic Attack (TIA)
Deep Vein Thrombosis or Pulmonary Embolism
Chronic Renal Disease or Hemodialysis
Significant Auto-Immune or Inflammatory conditions such as Rheumatoid Arthritis, Lupus, Crohn's Disease, etc.
Alzheimer's or Parkinson's Disease
Diabetes (Hemoglobin A1C > 6.5% or fasting glucose > 126 mg/dL or is treated with insulin or oral diabetic medication
Aortic or Cerebral Aneurysm

Currently taking any of the following medications on a regular basis:

Chemotherapeutic agents (ex. Tamoxifen, Doxorubicin, Mitoxantrone, bleomycin
Anti-platelet or anticoagulant agents, not including Aspirin (ex. Clopidogrel/Plavix, Dipyridamole/Aggrenox/Persantine, Ticlopidine/Ticlid, Warfarin/Coumadin, Prasugrel, etc.)
Cholinesterase inhibitor for Alzheimer's disease (ex. Donzepril/Aricept)
Insulin or oral diabetic medication
Individual has a significant medical condition which, in the investigator's opinion, may interfere with the individual's optimal participation in the study or would potentially confound interpretation of the individual's phenotype.

Study is for people with:

Breast Cancer

Estimated Enrollment:

15

Study ID:

NCT01816880

Recruitment Status:

Completed

Sponsor:

Scripps Translational Science Institute

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There is 1 Location for this study

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Scripps Translational Science Institute
La Jolla California, 92037, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

15

Study ID:

NCT01816880

Recruitment Status:

Completed

Sponsor:


Scripps Translational Science Institute

How clear is this clinincal trial information?

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