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Protocol Details

A Multi-Center Natural History of Urothelial Cancer and Rare Genitourinary Tract Malignancies

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

000302-C

Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18 Years
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

Fetuses;
Adults who are or may become unable to consent;
Pregnant Women;
Children;
Neonates

Keywords

bladder/urachal adenocarcinoma;
renal tumors;
penile cancers;
small cell neuroendocrine carcinoma of the prostate;
Renal Cell Carcinoma;
Natural History

Recruitment Keyword(s)

None

Condition(s)

Urothelial Cancer;
Bladder Cancer;
Genitourinary Cancer;
Urogenital Neoplasms;
Urogenital Cancer

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Cancer Institute

Background:

Tumors in the genitourinary tracts can occur in the kidney, bladder, prostate, and testicles and can have common and rare histologies. Some cancers that occur along the genitourinary (GU) tract are rare. Some GU tumors are so rare that they are not included in treatment studies or tissue banks. This makes it hard for researchers to determine standards of care. Researchers want to learn more about common and rare GU tumors.

Objective:

To learn more about urinary tract cancers.

Eligibility:

People ages 18 and older with urinary tract or GU cancer such as bladder, kidney, testicular, prostate, penis, or neuroendocrine cancer.

Design:

Participants will be screened with questions about their medical history. Their medical records will be reviewed.

Participants will have a physical exam. They will give blood and urine samples. They will complete a survey about their family cancer history. Clinical photographs will be taken to document skin lesions.

Participants may have imaging scans of their chest, abdomen, and pelvis. They may have a contrast agent injected into their arm.

Participants will get recommendations about how to best manage and treat their cancer. They can ask as many questions as they would like.

Participants will provide existing tumor samples if available. They may have optional tumor biopsies up to twice a year. For needle biopsies, the biopsy area will be numbed and they will get a sedative. A needle will be inserted through their skin to collect a tumor sample. For skin biopsies, their skin will be numbed. A small circle of skin will be removed.

Some blood and tumor samples may be used for genetic tests.

Participants will have frequent follow-up visits. If they cannot visit NIH, their home doctor will be contacted. They will be followed on this study for life.

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Eligibility

INCLUSION CRITERIA:

-Participants must have histologically or cytologically confirmed urothelial or rare genitourinary cancer including but not limited to the following: small cell carcinoma of the bladder; adenocarcinoma of the bladder; squamous cell carcinoma of the bladder; plasmacytoid urothelial carcinoma; any penile cancer; any testicular cancer, sarcomatoid renal cell carcinoma; sarcomatoid urothelial carcinoma; renal medullary carcinoma or other miscellaneous histologic variants of the urothelial carcinoma, such as, but not limited to micropapillary, giant cell, lipid-rich, clear cell and nested variants, large cell neuroendocrine carcinoma, lymphoepithelioma-like carcinoma and mixed patterns will be considered, as well as small cell neuroendocrine prostate cancer, testicular Sertoli or Leydig cell tumors. Any genitourinary cancer can be included at the principal investigator s discretion.

-Age >= 18 years.

-Ability of subject to understand and the willingness to sign a written informed consent

document.

EXCLUSION CRITERIA:

-Pregnancy


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Andrea B. Apolo, M.D.
National Cancer Institute (NCI)
NIHBC 10 - CLINICAL CENTER BG RM 13N240
10 CENTER DR
BETHESDA MD 20892
(301) 480-0536
apoloab@mail.nih.gov

Tzu-Fang Wang, R.N.
National Cancer Institute (NCI)
National Institutes of Health
Building 10
Room 13N254
10 Center Drive
Bethesda, Maryland 20892
(240) 858-3236
tzu-fang.wang@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:

NCT04923178

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