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Spots Global Cancer Trial Database for Changes in Semen or Sperm Caused by Temozolomide in Patients With Newly Diagnosed, Progressive, or Recurrent Primary Malignant Brain Tumors

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Trial Identification

Brief Title: Changes in Semen or Sperm Caused by Temozolomide in Patients With Newly Diagnosed, Progressive, or Recurrent Primary Malignant Brain Tumors

Official Title: Temozolomide Induced Changes in Semen/Sperm Analysis in Men With Newly Diagnosed, Progressive or Recurrent Primary Malignant Brain Tumors

Study ID: NCT00499798

Interventions

Study Description

Brief Summary: RATIONALE: Learning whether temozolomide changes semen or sperm in patients with brain tumors may help doctors learn about the long-term effects of treatment and plan the best treatment. PURPOSE: This clinical trial is studying changes in semen or sperm caused by temozolomide in patients with newly diagnosed, progressive, or recurrent primary malignant brain tumors.

Detailed Description: OBJECTIVES: Primary * Assess if temozolomide induces any changes in standard semen or sperm analysis parameters (i.e., volume, viscosity, pH, forward progression, total count, total motile count, motility, presence of round cells, agglutination, and morphology) in patients with newly diagnosed, recurrent, or progressive primary malignant brain tumors. OUTLINE: This is a pilot study. During treatment with temozolomide, patients undergo semen or sperm sample collection at baseline, 3 months, and 6 months for semen analysis. Samples are analyzed for volume, viscosity, pH, forward progression, total count, total motile count, motility, presence of round cells, agglutination, and morphology.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT

Sex: MALE

Healthy Volunteers: No

Locations

Wake Forest University Comprehensive Cancer Center, Winston-Salem, North Carolina, United States

Contact Details

Name: Glenn J. Lesser, MD

Affiliation: Wake Forest University Health Sciences

Role: STUDY_CHAIR

Name: Robert T. Blackwood, PA-S

Affiliation: Wake Forest University Health Sciences

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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