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Protocol Details

Ex-Vivo Trial of En-bloc Transurethral Resection of Bladder Tumor (En-bloc TURBT) specimens using Modified Existing Surgical Resectoscope Device

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

20-C-0020

Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

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

Referral Letter Required

No

Population Exclusion(s)

Pregnant Women and Fetuses;
Children

Special Instructions

Currently Not Provided

Keywords

TURBT;
Transurethral Resection of Bladder Tumors;
Cystectomy;
Modified Resectoscope

Recruitment Keyword(s)

None

Condition(s)

Bladder Cancer

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Cancer Institute

Background:

Bladder cancer is the sixth most common cancer in the United States. The way that doctors remove tumors in bladder surgeries may leave some cancer . Also, many people have their tumors return or progress after surgery. Researchers want to test a modified device. It might tell doctors more about bladder tumors.

Objective:

To see if using a modified standard device with bladder surgery can provide better information about tumors in bladder specimens.

Eligibility:

People ages 18 and older who need to have their bladder removed at the NIH.

Design:

Participants will be screened with:

Medical and prior surgical history

Review of existing MRI, x-ray, or CT scans

Review of existing specimens and reports

Pregnancy test for women of childbearing age

CT or MRI: Participants will lie in a machine. The machine will take pictures of their body.

Participants will have bladder surgery. This will occur in the same way as if they did not take part in this study. A member of the research team will cut the removed bladder using the modified device. This will most likely be done on a separate back table in the operating room. The bladder and samples after cutting will be sent out for review. The will occur just as it would if the participants were not in this study. The only difference is the way that the specimen is prepared for review.

Participants follow-up care will occur per standard of care. Or it will occur as part of any other study in which they might also be enrolled.

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Eligibility

INCLUSION CRITERIA:

- Patients requiring surgical removal of the bladder at the NIH Clinical Center.

NOTE: Reasons for need for surgical removal of bladder include cancer or benign condition for which a surgeon determined surgical removal of the bladder is recommended. Patient's with invasive bladder cancer requiring cystectomy are eligible for enrollment. Bladder cancer remains the most common reason for cystectomy. Patients with clinical advanced disease and having other treatments/or participating in other trials remain eligible for enrollment in this study.

- Men and women

- Age greater than or less than 18 years

- Deemed clinically appropriate for the planned surgical procedure.

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

- Subjects will be asked to co-enroll in 15-C-0087, "Care of the Urothelial Cancer Patient and Prospective Collection of Biospecimens from Healthy Volunteers and Urothelial Cancer Patients." NOTE: Most participants are expected to already be enrolled in 15-C-0087 prior to entry in this study.

EXCLUSION CRITERIA:

- Cystectomy during pregnancy would subject the fetus to significant risk of miscarriage or premature labor. For this reason, pregnant women are ineligible for this study.


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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)



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:

NCT04235764

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