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| ID | Type | Description | Link |
|---|---|---|---|
| 04-C-0274 |
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This study aims to provide long-term follow-up care of patients previously enrolled in a vaccine study that involved poxviral vectors. Vectors are sequences of genetic material that can be used to introduce specific genes into genetic makeup. The study does not involve the use of any drug or biologic agent. Participants will undergo an annual health history. Because certain viruses enter into cells and create proteins from the viral genes, the type of vaccine treatment used is referred to gene therapy. The genes expressed by poxviral vectors do not become part of the genetic material left behind. Because gene therapy is a somewhat new technology, a prolonged monitoring of patients' health status is necessary, according to new specific reporting requirements for harmful events in patients who undergo such gene therapy studies. The risk of any long-term negative effects from the gene therapy that patients had received is quite small. Still, it is important that there be updates at least annually. This annual monitoring of health status will extend for 15 years, according to guidelines from the Food and Drug Administration, or for as long as patients are willing to participate.
Patients who received poxviral vectors (vaccinia or fowlpox, or both) at the National Cancer Institute, through a trial affiliated with the Laboratory of Tumor Immunology and Biology, may be eligible for this study.
Participants will be involved in the following forms of data collection:
If a participant has died, the study will document the cause of death and autopsy information if available.
This protocol aims to provide long-term follow-up and continued use of research specimens of participants previously enrolled on gene transfer or other immunotherapy studies at the National Cancer Institute as well as follow-up of subjects at extramural sites receiving these agents as part of a multi-site trial. Subjects will undergo an annual health history for up to 15 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Subjects previously participating in gene transfer or other immunotherapy studies at the NCI or extramural sites receiving therapeutic agents as part of a multi-site trial. |
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| Measure | Description | Time Frame |
|---|---|---|
| To provide a mechanism for adequate follow-up of subjects previously participating in gene transfer or other immunotherapy studies at the National Cancer Institute as required by the U.S. Food and Drug Administration. | Annual history and physical examinations for the first 5 years of follow-up and an annual telephone contact during the next 10 years. | on-going |
| To facilitate the continuous usage of stored research specimens collected from subjects under completed and ongoing protocols. | Continued analysis on stored specimen samples until the samples are completely used. | on-going |
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EXCLUSION CRITERIA:
Participants unwilling to participate.
(Please note, participants may participate in this protocol and, at the same time, participate in an active treatment or continuing care study.)
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Subjects who received poxviral vectors (vaccinia and/or fowlpox) or other vaccines utilizing gene transfer or any other immunotherapeutic agent through GMB, UOB and LTIB affiliated trials at the National Cancer Institute, as well as subjects at extramural sites receiving these agents as part of a multi-site trial. These studies include (but are not limited to) the following NCI protocol numbers : 00-C-0137, 00-C-0154, 02-C-0218, 03-C-0176, 04-C-0167, 04-C-0246, 05-C-0017, 05-C-0167, 05-C-0229, 07-C-0106, 07-C-0107, 07-C-0188, 08-C-0166, 09-C-0101,11-C-0225, 12-C-0056, 13-C-0146, 13-C-0153, 13-C-0095, 14-C-0142, 14-C-0112, 15-C-020511-C-0247, 11-C-0262, 13-C-0063, 14-C-0090, 15-C-0012, 15-C-0118, 15-C-0145, 15-C-0178, 15-C-0179, 16-C-0035, 16-C-0048, 16-C-0079, 17-C-0007, 17-C-0023, 17-C-0038, 17-C-0057, and 17-C-0061.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sheri A McMahon, R.N. | Contact | (240) 760-7968 | sheri.mcmahon@nih.gov | |
| Jennifer L Marte | Contact | (301) 496-7214 | martej@mail.nih.gov |
| Name | Affiliation | Role |
|---|---|---|
| Jennifer L Marte | National Cancer Institute (NCI) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institutes of Health Clinical Center | Recruiting | Bethesda | Maryland | 20892 | United States |
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| Label | URL |
|---|---|
| NIH Clinical Center Detailed Web Page | View source |
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All IPD recorded in the medical record will be shared with intramural investigators upon request.
Clinical data available during the study and indefinitely.
Clinical data will be made available via subscription to BTRIS and with the permission of the study PI.
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D008113 | Liver Neoplasms |
| D001943 | Breast Neoplasms |
| D003110 | Colonic Neoplasms |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |