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Protocol Details

Care of the Urothelial Cancer Patient and Prospective Collection of Biospecimens from Healthy Volunteers and Urothelial Cancer Patients

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

15-C-0087

Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18
Max Age: 100

Referral Letter Required

No

Population Exclusion(s)

Children;
Pregnant Women and Fetuses

Special Instructions

Currently Not Provided

Keywords

Specimen Collection;
Urine;
Blood;
Saliva

Recruitment Keyword(s)

None

Condition(s)

Bladder Cancer;
Urinary Tract Cancer;
Urothelial Cancer;
Healthy Volunteers

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Cancer Institute

Background:

Urothelial cancer is cancer of the bladder, ureter, and urethra. Researchers want to better understand what changes in a person s cells and genes cause this cancer to form. This may help them find new ways to treat it.

Objective:

- To perform DNA sequencing to help researchers learn the differences between normal tissue and tumor tissue. Also, to learn how molecular changes - including gene changes - might help predict the course of disease and how people respond to therapy.

Eligibility:

- Adults age 18 and older who have or are suspected of having urothelial cancer or an inherited disorder that raises their risk of getting bladder cancer.

Design:

- Participants will be screened with a physical exam. Their medical records and tissue samples will be reviewed.

- Eligible participants will give tissue blocks of their original tumor. The blocks will be put in a tissue bank.

- Participants medical records may be reviewed.

- Participants may have a medical history and physical exam.

- Participants may have blood and urine tests. They may have imaging scans. They may give urine, blood, and saliva samples. These samples may be used in future research.

- If participants need surgery for their cancer, researchers will keep some of the tissue (both tumor and normal tissue). The tissue may be used in future research.

- Participants will go back to the Clinical Center in 6 months. They may give saliva, urine, and blood samples. After 6 months, they will be seen by their local doctor for standard post-surgical visits.

- Participants will be called every 6 months to give health updates.

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Eligibility

INCLUSION CRITERIA:

-Adults (>= 18 years of age) with biopsy-proven or suspected urothelial cancer who require and are willing to undergo diagnostic or therapeutic intervention as part of their diagnosis, standard of care treatment, or follow-up/surveillance for their neoplasm.

-ECOG performance status of 0-3.

-Must be willing and able to provide informed consent.

EXCLUSION CRITERIA:

-Subjects who are pregnant.

-Subjects co-morbidities preclude diagnostic or therapeutic intervention. Co-morbidities include:

--Ongoing treatment for another non-skin malignancy.

-History of hepatitis B/C or HIV. Patients who are HIV positive are excluded from this study because treatment with immunomodulatory agents for immunosuppressed patients would affect sample analysis and skew the data.

ELIGIBILITY CRITERIA FOR HEALTHY VOLUNTEERS (NCI ONLY)

INCLUSION CRITERIA:

-Adults (greater than or equal to 18 years of age) and able to give informed consent.

EXCLUSION CRITERIA:

-Subjects who are pregnant.

-Diagnosis of cancer requiring treatment other than minor resection of basal cell or squamous cell skin cancers.

-Heart, lung, kidney disease, or other medical conditions as per Principal Investigator discretion.

-History of acute or chronic hepatitis B/C or HIV infection. Patients who are HIV positive are excluded from this study because treatment with immunomodulatory agents for immunosuppressed patients would affect sample analysis and skew the data.

-Healthy volunteers who are family members with germline mutations.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Vladimir A. Valera Romero, M.D.
National Cancer Institute (NCI)
BG 10-CRC RM 1-5940
10 CENTER DR
BETHESDA MD 20814
(301) 496-6353
vladimir.valeraromero@nih.gov

Sonia E. Bellfield, R.N.
National Cancer Institute (NCI)
National Institutes of Health
Building 10
Room 6B04
10 Center Drive
Bethesda, Maryland 20892
(240) 760-6118
sonia.bellfield@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:

NCT02379429

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