Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Leukemia

Hematologic Neoplasms

Leukemia, B-Cell

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Leukemia, Lymphoid

Lymphatic Diseases

Subjects who have received treatment on an NCI Surgery Branch CAR T-cell gene therapy protocols.

James N Kochenderfer, M.D.

Background:

- Gene therapy is a way to treat or prevent disease using genes. It is monitored very closely by regulators because there can be long-term, unexpected side effects. NIH is required to try to contact people who have been treated with gene therapy at least annually for up to 15 years. This is to see if they have had any bad side effects. This trial does not include any therapy and is only for patients previously treated on gene-therapy trials at the NCI Surgery Branch who are no longer enrolled on their original gene therapy clinical trial.

Objective:

- To collect of long-term follow-up data on people who have been in gene transfer studies. This follow-up is required by regulators.

Eligibility:

- People age 18 and older who have been in a previous NCI Surgery Branch gene therapy research study.

Design:

* After they get the genetically modified cells, participants will:
* Have blood drawn 3, 6, and 12 months later.
* Have an annual clinic visit for the next 4 years. They will have a physical exam. They will answer questions about any signs of neurological, autoimmune, or blood disorders, or any new cancers. Blood may be drawn.
* Be called or emailed annually for the next 10 years. They will answer health questions. Blood samples may need to be taken.
* Participants will be asked for their current address and phone number. They will also be asked for the address and phone number of 1 or 2 people who will know their whereabouts. One of these should be a family member if possible,
* At the time of the participant s death, researchers will request permission from their family for an autopsy.

Background:

-The National Cancer Institute Surgery Branch (NCI-SB) Branch investigator conducts clinical trials utilizing gene transfer. The current U.S. Food and Drug Administration (FDA) requirements for long term follow up may be up to fifteen years for some products. As this time period is frequently longer than studies are expected to be open, a long-term follow-up protocol is necessary to ensure the follow up of these subjects

Objectives:

-To facilitate collection of long term, follow up information on subjects who have participated in gene transfer studies as required by the U.S. Food and Drug Administration and other regulatory groups

Eligibility:

-Enrollment on a CAR T-cell treatment protocol for gene therapy.

Design:

-Patients will undergo physical exams; laboratory evaluation or phone follow up as required by the treatment protocol and/or as clinically indicated.

Gene Therapy Follow-up Protocol for People Previously Enrolled in CAR-T Cell Studies

Gene Therapy Follow up Protocol for Subjects Previously Enrolled in CAR T-Cell Studies

List of long time adverse event frequency after Gene therapy drug

National Cancer Institute (NCI)

Diseases and Abnormalities at or Before Birth

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Congenital Abnormalities

Abortion, Spontaneous

Pregnancy Complications

Urogenital Diseases

Female Urogenital Diseases

Female Urogenital Diseases and Pregnancy Complications

All Drugs and Chemicals

Hormones

Vincent F Garry, MD

This project is designed to establish whether pesticides or other environmental agents have a role in the excess birth defects identified in the Red River Valley of Minnesota. In this human study, laboratory based health parameters will be used to key in health survey data. In vitro data will be developed to mechanistic information. Concordant results among these study features will provide a weight of evidence approach.

Pesticides--Health Fertility and Reproductive Risk

National Institute of Environmental Health Sciences (NIEHS)

Digestive System Diseases

Gland and Hormone Related Diseases

Carcinoma

Pancreatic Neoplasms

Neoplasms, Cystic, Mucinous, and Serous

Pancreatic Intraductal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Neoplasms, Glandular and Epithelial

Pancreatic Cancer

Participants undergo resection. Resected tissues are analyzed via ultra-high resolution OCT.

Optical Coherence Tomography

Therapeutic Conventional Surgery

Labs will be obtained to test for cancer cell derived exosomes

Laboratory Evaluation

Ohio State University Comprehensive Cancer Center

Mary E. Dillhoff, MD

Mary Dillhoff, MD

This trial studies how well ultra-high resolution optical coherence tomography works in detecting micrometer sized early stage pancreatic cancer in participants with pancreatic cancer. Ultra-high resolution optical coherence tomography may help to accurately identify pancreatic cancer in resected pancreatic specimens.

PRIMARY OBJECTIVES:

I. To evaluate the using of optical coherence tomography (OCT) to diagnose pancreatic cancer arising in the setting of intraductal papillary mucinous neoplasms (IPMN) using the resected pancreatic specimen.

II. To correlate OCT imaging diagnosis with histologic findings in the human pancreatic duct.

IPMN is a premalignant lesions arising in the pancreas. Typically, IPMNs are identified incidentally on imaging performed for other reason or related to vague abdominal pain or gastrointestinal complaints. In terms of IPMN, invasive cancer can be found in this setting between 20 to 50% of the time\[7\] Therefore, if a patient is diagnosed with IPMN, especially main duct type, the general recommendation is to undergo resection. We propose to assess the duct of the pancreatic specimen after resection to identify evidence of invasive malignancy by OCT imaging. Afterwards, the specimen will be undergoing histopathologic assessment using standard protocols. Our hypothesis is that OCT will accurately identify pancreatic cancer in resected pancreatic specimen. The assessment with OCT is non-invasive and will not harm to change the specimen prior to going to pathology for standard review. Future studies will then focus on using this imaging technique in vivo to endoscopically identify early stage pancreatic cancer.

Ultra-High Resolution Optical Coherence Tomography in Detecting Micrometer Sized Early Stage Pancreatic Cancer in Participants With Pancreatic Cancer

Imaging and Detection of Micrometer Sized Early Stage Pancreatic Cancer by Using Endoscopic Ultra-High Resolution Optical Coherence Tomography (OCT) Using Resected Pancreatic Specimen, a Pilot Study

Will evaluate the accuracy of the optical coherence tomography (OCT) based diagnosis compare to the pathological diagnosis or the cancer cell derived exosomes test from the blood sample. Will compare the diagnosis results from the OCT imaging technology to standard histopathologic assessment and the blood test using 2-way tables. The agreement between two tests will be summarized with the overall agreement and the Cohen?s Kappa values.

Principal Investigator

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Uterine Cervical Neoplasms

Oropharyngeal Neoplasms

Squamous Intraepithelial Lesions of the Cervix

Uterine Cervical Dysplasia

Precancerous Conditions

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Head and Neck Neoplasms

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

Cervical Intraepithelial Neoplasia

Subjects who have received treatment on an NCI CIO or CIO gene therapy protocol.

Observation/ Gene Therapy Long-term Follow-up. Subjects who have received treatment on an applicable NCI CIO gene therapy protocol.

GeneTherapy

Scott M Norberg, D.O.

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.

...

Background:

The NCI CIO conducts clinical trials utilizing gene transfer. The current FDA requirements for long term follow up may be up to fifteen years for some products. As this time period is frequently longer than studies are expected to be open, a protocol is necessary to ensure the necessary follow up of these subjects

Objectives:

To facilitate collection of long term follow up information on subjects who have participated in gene transfer studies as required by the U.S. Food and Drug Administration and other regulatory groups

Eligibility:

Enrollment on a NCI CIO treatment protocol for gene therapy.

Design:

Patients will undergo physical exams, laboratory evaluations and/or phone follow up as required by the treatment protocol and/or as clinically indicated.

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Gene Therapy Follow-up Protocol for People Previously Enrolled in CAR-T Cell Studies	NCT02473757	Lyphoma, B-Cell Leukemia, B-cel... Multiple Myelom... Hematologic Mal...		18 Years -	National Institutes of Health Clinical Center (CC)
Pesticides--Health Fertility and Reproductive Risk	NCT00015561	Birth Defects Miscarriages Cancer		18 Years - 70 Years	National Institute of Environmental Health Sciences (NIEHS)
Ultra-High Resolution Optical Coherence Tomography in Detecting Micrometer Sized Early Stage Pancreatic Cancer in Participants With Pancreatic Cancer	NCT03711890	Pancreatic Carc... Pancreatic Intr...	Optical Coheren... Therapeutic Con... Laboratory Eval...	18 Years -	Ohio State University Comprehensive Cancer Center
Gene Therapy Follow-up Protocol for People Previously Enrolled in CAR-T Cell Studies	NCT02473757	Lyphoma, B-Cell Leukemia, B-cel... Multiple Myelom... Hematologic Mal...		18 Years -	National Institutes of Health Clinical Center (CC)
Gene Therapy Follow up Protocol for Subjects Previously Enrolled in NCI Center for Immuno-Oncology Studies	NCT04266093	Cervical Intrae... Cervical Neopla... Oropharyngeal N... Squamous Intrae... Hematologic Mal...	GeneTherapy	18 Years - 120 Years	National Institutes of Health Clinical Center (CC)

Spots Global Cancer Trial Database for laboratory evaluation