Advertisement

Topics

Long-Term Follow-Up of Recipient of Gene Transfer Research

2014-09-30 16:38:23 | BioPortfolio

Summary

The goal of this clinical research study is to collect information about the long-term safety of gene transfer therapy. This study is also designed to create a database of medical information about patients who have received gene transfer therapy, in order for researchers to track and review the long-term safety and any effects (good or bad) of gene transfer therapy.

Description

Study Procedures for Years 1-5:

If you agree to take part in this study, you will come to the clinic for study visits once a year during Years 1-5. It is your choice whether to visit your regular local doctor or your study doctor at MD Anderson. (If you visit your regular local doctor, you will need to have your test results and blood samples mailed to the study staff.) You will receive a reminder phone call once a year, when it is time to schedule these visits.

At these visits, the following procedures will be performed:

- Blood (about 2-4 tablespoons each time) will be drawn for routine tests.

- You will have a physical exam, including measurement of your vital signs (blood pressure, heart rate, temperature, and breathing rate).

- You will fill out a questionnaire that asks about your medical history (your general health, the status of any medical conditions, and any illnesses or hospitalizations that may have occurred). It should take about 15-30 minutes to complete.

- You will be asked if there have been any changes in your contact information.

- If necessary to check the status of the disease, you will have scans (x-rays and/or computed tomography [CT] scans) and/or additional routine blood tests (about 1-2 tablespoons).

Study Procedures for Years 6-15:

Once a year during Years 6-15, the research staff will contact you. Either over the phone, by email, or by mail (but usually by mail, with an enclosed questionnaire), you will be asked about your medical history (including if you have had any children since the infusion) and whether there have been any changes in your contact information. The phone calls and questionnaires should take about 15-30 minutes each time.

Blood Tests for RCR:

The study doctor will tell you if the type of gene transfer therapy you received was called "retroviral" therapy. If so, you will have an additional blood test performed to check to make sure you do not have a type of infection called the replication-competent retrovirus (RCR). For this test, blood (up to 4 tablespoons each time) will drawn every 3 months for the first year after your gene transfer therapy and once a year after that. (If you join this study more than a year after your gene transfer therapy, however, this RCR test will be performed once a year for all 15 years of the study, rather than your having the blood draws every 3 months in Year 1.)

For these RCR blood tests, it is your choice whether to visit your regular local doctor your study doctor at MD Anderson. If you visit your regular local doctor, you will need to have your test results and blood samples mailed to either the National Gene Vector Biorepository and Coordinating Center (NGVB) or MD Anderson. The study staff will tell you where to have the results and samples mailed, and you will receive a kit with supplies for mailing the blood samples.

If the RCR test results during Year 1 of the study show that you do not have the RCR infection, the rest of your leftover blood samples (left over from RCR testing in Years 2-15) will be stored at MD Anderson for safety reasons. This is so researchers can study any changes in your blood (related to RCR) that may arise in Years 2-15.

Results of Study Testing:

If any of the tests that are performed in this study suggest that you may have a medical condition and/or side effect that is likely to be related to the gene transfer therapy, the study doctor will contact you. (This includes, for example, the RCR infection described above). You will receive a referral in case you would like to seek medical care for the condition and/or side effect.

Study Database:

Your medical information that is collected for this study will be stored in a research database at MD Anderson for use in future research related to the safety and effects of gene transfer therapy.

Length of Study Participation:

After 15 years, your participation in this study will be over unless the FDA decides that follow-up must continue.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Conditions

Retroviridae Infections

Intervention

Blood Tests, Questionnaires

Location

University of Texas MD Anderson Cancer Center
Houston
Texas
United States
77030

Status

Recruiting

Source

M.D. Anderson Cancer Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-09-30T16:38:23-0400

Clinical Trials [1335 Associated Clinical Trials listed on BioPortfolio]

Pioglitazone to Treat Fatty Liver in Patients With HIV and Hepatitis C Infections

This study will evaluate the effectiveness of pioglitazone in reducing liver fat content in patients with HIV and hepatitis C virus (HCV) infections. Fatty liver and accompanying insulin r...

3 Minutes Chair Rise Test (3CRT) in Patients With COPD

Improvement in the functional functioning and dyspnea of COPD patients after a rehabilitation program (RHB) is assessed by exercise tests and questionnaires difficult to replicate outside ...

Voriconazole to Prevent Systemic Fungal Infections in Children

This study will examine how children's bodies metabolize and eliminate the anti-fungal drug voriconazole. The results will yield information needed to make recommendations for safe and ef...

Medical Implications of Coinfection With Malaria and Filariasis Parasites

This study will examine the clinical, immunological and epidemiological effects of concurrent infections with P. falciparum and W. bancrofti or M. perstans (the parasites that cause malari...

Mycobacterial and Opportunistic Infections in HIV-Negative Thai and Taiwanese Patients Associated With Autoantibodies to Interferon-gamma

Opportunistic infections are caused by bacteria, mycobacteria, fungi or viruses that do not normally cause infections in people with healthy immune systems. Some of these infections can ca...

PubMed Articles [14516 Associated PubMed Articles listed on BioPortfolio]

Comparison of three blood transfusion guidelines applied to 31 feline donors to minimise the risk of transfusion-transmissible infections.

Objectives The increased demand for animal blood transfusions creates the need for an adequate number of donors. At the same time, a high level of blood safety must be guaranteed and different guideli...

Zika Virus Infection and Prolonged Viremia in Whole-Blood Specimens.

We tested whole-blood and plasma samples from immunocompetent patients who had had benign Zika virus infections and found that Zika virus RNA persisted in whole blood substantially longer than in plas...

Repetition of blood testing : which risks for the patient?

Numerous tests are performed in the hospital, often on a daily basis. These tests should answer a specific scientific question and be performed only if their results can have an impact on patient care...

Hepatitis B and C Virus Infections Among Human Immunodeficiency Virus-Infected People Who Inject Drugs in Lahore, Pakistan.

Hepatitis B virus (HBV) and hepatitis C virus (HCV) are the major cause of the global burden of hepatitis. One of the main routes of transmission for both viruses is through exposure to infected blood...

Massive splenomegaly due to concurrent primary Epstein-Barr virus and cytomegalovirus infection in a patient on adalimumab.

A 32-year-old man who was receiving adalimumab for seronegative rheumatoid arthritis presented with a 4-week history of fever, night sweats, fatigue, myalgias and diarrhoea. On examination, he had obv...

Medical and Biotech [MESH] Definitions

Virus diseases caused by the RETROVIRIDAE.

Inflammation of brain parenchymal tissue as a result of viral infection. Encephalitis may occur as primary or secondary manifestation of TOGAVIRIDAE INFECTIONS; HERPESVIRIDAE INFECTIONS; ADENOVIRIDAE INFECTIONS; FLAVIVIRIDAE INFECTIONS; BUNYAVIRIDAE INFECTIONS; PICORNAVIRIDAE INFECTIONS; PARAMYXOVIRIDAE INFECTIONS; ORTHOMYXOVIRIDAE INFECTIONS; RETROVIRIDAE INFECTIONS; and ARENAVIRIDAE INFECTIONS.

Viral infections of the leptomeninges and subarachnoid space. TOGAVIRIDAE INFECTIONS; FLAVIVIRIDAE INFECTIONS; RUBELLA; BUNYAVIRIDAE INFECTIONS; ORBIVIRUS infections; PICORNAVIRIDAE INFECTIONS; ORTHOMYXOVIRIDAE INFECTIONS; RHABDOVIRIDAE INFECTIONS; ARENAVIRIDAE INFECTIONS; HERPESVIRIDAE INFECTIONS; ADENOVIRIDAE INFECTIONS; JC VIRUS infections; and RETROVIRIDAE INFECTIONS may cause this form of meningitis. Clinical manifestations include fever, headache, neck pain, vomiting, PHOTOPHOBIA, and signs of meningeal irritation. (From Joynt, Clinical Neurology, 1996, Ch26, pp1-3)

Scales, questionnaires, tests, and other methods used to assess pain severity and duration in patients or experimental animals to aid in diagnosis, therapy, and physiological studies.

Laboratory tests for evaluating the individual's clotting mechanism.

More From BioPortfolio on "Long-Term Follow-Up of Recipient of Gene Transfer Research"

Quick Search
Advertisement
 

Relevant Topics

Bioinformatics
Bioinformatics is the application of computer software and hardware to the management of biological data to create useful information. Computers are used to gather, store, analyze and integrate biological and genetic information which can then be applied...

Cardiovascular disease (CVD)
Acute Coronary Syndromes (ACS) Blood Cardiovascular Dialysis Hypertension Stent Stroke Vascular Cardiovascular disease (CVD) includes all the diseases of the heart and circulation including coronary heart disease (angina...

Nutrition
Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...


Searches Linking to this Trial