Ignite Creation Date:
2024-05-05 @ 6:32 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00499798
Status:
COMPLETED
Last Update Posted:
2017-05-30
First Post:
2007-07-10
Brief Title:
Changes in Semen or Sperm Caused by Temozolomide in Patients With Newly Diagnosed Progressive or Recurrent Primary Malignant Brain Tumors
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
Temozolomide Induced Changes in SemenSperm Analysis in Men With Newly Diagnosed Progressive or Recurrent Primary Malignant Brain Tumors
Status:
COMPLETED
Status Verified Date:
2013-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 ie 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
Primary
Assess if temozolomide induces any changes in standard semen or sperm analysis parameters ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CCCWFU-BG04-308 | None | None | None |
| CCCWFU-97404 | None | None | None |