Ignite Creation Date:
2025-12-24 @ 5:31 PM
Ignite Modification Date:
2025-12-29 @ 8:47 PM
Study NCT ID:
NCT00900068
Status:
TERMINATED
Last Update Posted:
2017-05-09
First Post:
2009-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Blood Samples From Patients on a Clinical Trial to CINV During HSCT
Sponsor:
OHSU Knight Cancer Institute
Organization:
Study Overview
Official Title:
Substance P Follow-up to a Pilot Study of Aprepitant vs Placebo Combined With Standard Antiemetics for the Control of Nausea and Vomiting During Hematopoietic Cell Transplantation
Status:
TERMINATED
Status Verified Date:
2017-05
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: Studying samples of blood in the laboratory from patients with cancer may help doctors learn more about nausea and vomiting caused by cancer treatment.
PURPOSE: This laboratory study is looking at blood samples from patients with cancer who were treated on a clinical trial to control nausea and vomiting during donor stem cell transplant.
PURPOSE: This laboratory study is looking at blood samples from patients with cancer who were treated on a clinical trial to control nausea and vomiting during donor stem cell transplant.
Detailed Description:
OBJECTIVES:
Primary
* To compare the amount of substance P in serum samples from patients with cancer treated with busulfan/cyclophosphamide or cyclophosphamide/total body irradiation conditioning regimens prior to undergoing allogeneic hematopoietic stem cell transplantation.
Secondary
* To assess the changes in substance P over time to see if there is an optimal time shown by this physiologic correlate to discontinue substance P blockade after the chemotherapy regimen is completed in these patients.
OUTLINE: Previously collected serum samples are analyzed by enzyme immunoassay for changes in substance P levels.
Patients' medical records are reviewed for demographic information, past history, and course of treatment.
Primary
* To compare the amount of substance P in serum samples from patients with cancer treated with busulfan/cyclophosphamide or cyclophosphamide/total body irradiation conditioning regimens prior to undergoing allogeneic hematopoietic stem cell transplantation.
Secondary
* To assess the changes in substance P over time to see if there is an optimal time shown by this physiologic correlate to discontinue substance P blockade after the chemotherapy regimen is completed in these patients.
OUTLINE: Previously collected serum samples are analyzed by enzyme immunoassay for changes in substance P levels.
Patients' medical records are reviewed for demographic information, past history, and course of treatment.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| P30CA069533 | NIH | None | https://reporter.nih.gov/quic… | View |
| OHSU-CPC-08055-L | None | None | View | |
| OHSU-IRB 4517 | None | None | View | |
| MERCK-OHSU-CPC-08055-L | None | None | View |