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Protocol Details

Gene Therapy Follow up Protocol for Subjects Previously Enrolled in NCI Center for Immuno-Oncology Studies

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

20-C-0051

Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Enrolling by Invitation
Gender: Male & Female
Min Age: 18 Years
Max Age: 120 Years

Referral Letter Required

Yes

Population Exclusion(s)

Fetuses;
Pregnant Women;
Children

Keywords

Gene Transfer;
Recombinant DNA Product;
Gamma-Retroviral Vectors;
Laboratory Evaluation;
Natural History

Recruitment Keyword(s)

None

Condition(s)

Cervical Intraepithelial Neoplasia;
Cervical Neoplasms;
Oropharyngeal Neoplasms;
Squamous Intraepithelial Lesions of the Cervix;
Hematologic Malignacies

Investigational Drug(s)

E7 transducted PBL

Investigational Device(s)

None

Intervention(s)

Drug: GeneTherapy

Supporting Site

National Cancer Institute

Background:

Gene therapy is closely followed by the U.S. Food and Drug Administration (FDA). The FDA requires researchers to conduct long-term follow-up of people who have had the treatment. This study collects data on people who have had gene therapy and sends it to the FDA. The data does not include participants names.

Objective:

To contact current or past participants of gene therapy protocols at least once a year for up to 15 years to ensure they have not had any harmful side effects.

Eligibility:

People aged 18 and older who have had gene therapy in a National Cancer Institute study

Design:

Participants will give their address and telephone number. They will also give and the address and phone number of 1 or 2 other people who will know where they are.

For the first year after gene therapy, participants will give blood samples 3 times (at 3, 6, and 12 months). For the next 4 years, they may have a physical exam and laboratory tests with a home physician. They will get a kit to mail in blood samples. Or they can visit the NIH Clinical Center. They will be asked if they have had any signs of neurological, autoimmune, or blood disorders, or any new cancers.

For years 6 to 15, participants will be contacted yearly via phone or email and asked questions about their health. They may give blood samples.

When the participant dies, if researchers think the death was caused by gene therapy, they will ask the participant s family to allow an autopsy.

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Eligibility

INCLUSION CRITERIA:

-Subjects who have received gene therapy on an applicable NCI CIO protocol. Age >= 18 years. Note: Children are generally excluded from CIO gene therapy studies and inclusion on this follow-up study will be limited to 18 years and older.

EXCLUSION CRITERIA:

-Children


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Scott M. Norberg, D.O.
National Cancer Institute (NCI)
NIHBC 10 - CLINICAL CENTER BG RM 13N240
10 CENTER DR
BETHESDA MD 20892
(301) 275-9668
scott.norberg@nih.gov

Erin W. Ferraro, R.N.
National Cancer Institute (NCI)
National Institutes of Health
Building 10
Room 3-3330
10 Center Drive
Bethesda, Maryland 20814
(240) 760-6163
erin.ferraro@nih.gov

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
1-888-NCI-1937

Clinical Trials Number:

NCT04266093

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