Ignite Creation Date:
2024-05-05 @ 5:01 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00369460
Status:
COMPLETED
Last Update Posted:
2015-10-12
First Post:
2006-08-24
Brief Title:
Changes in Muscle Tissue in Patients With Pancreatic Cancer
Sponsor:
Case Comprehensive Cancer Center
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
Pilot Study of Changes in Fat-Free Mass in Pancreatic Carcinoma Patients
Status:
COMPLETED
Status Verified Date:
2015-10
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 Measuring changes in muscle tissue in patients with cancer may help doctors predict how well patients will respond to treatment and may help the study of cancer in the future
PURPOSE This pilot study is evaluating changes in muscle tissue in patients with pancreatic cancer
PURPOSE This pilot study is evaluating changes in muscle tissue in patients with pancreatic cancer
Detailed Description:
OBJECTIVES
Demonstrate a decreaseincrease of fat-free mass FFM by 10 from baseline based on tumor progressionregression within each patient with inoperable locally advanced or metastatic pancreatic carcinoma
Determine the correlation between changes in FFM and 6-month survival
Confirm the frequency of lymphocytopenia in patients with inoperable locally advanced or metastatic pancreatic carcinoma
Demonstrate an interaction between pretreatment total lymphocyte count treatment response and 6-month survival in patients with inoperable locally advanced or metastatic pancreatic carcinoma
Collect adjuvant information such as weight body mass index age ECOG performance status gait speed concomitant medications CA19-9 and total lymphocyte count in these patients
OUTLINE This is a pilot study
Patients will have weight body mass index age ECOG performance status gait speed concomitant medications CA19-9 and total lymphocyte count measured before start of cancer treatment of the patients choosing
Patients will be re-assessed at approximately 2 months 4 months 6 months and with any change in tumor burden
PROJECTED ACCRUAL A total of 17 patients will be accrued for this study
Demonstrate a decreaseincrease of fat-free mass FFM by 10 from baseline based on tumor progressionregression within each patient with inoperable locally advanced or metastatic pancreatic carcinoma
Determine the correlation between changes in FFM and 6-month survival
Confirm the frequency of lymphocytopenia in patients with inoperable locally advanced or metastatic pancreatic carcinoma
Demonstrate an interaction between pretreatment total lymphocyte count treatment response and 6-month survival in patients with inoperable locally advanced or metastatic pancreatic carcinoma
Collect adjuvant information such as weight body mass index age ECOG performance status gait speed concomitant medications CA19-9 and total lymphocyte count in these patients
OUTLINE This is a pilot study
Patients will have weight body mass index age ECOG performance status gait speed concomitant medications CA19-9 and total lymphocyte count measured before start of cancer treatment of the patients choosing
Patients will be re-assessed at approximately 2 months 4 months 6 months and with any change in tumor burden
PROJECTED ACCRUAL A total of 17 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| CASE8205 | OTHER | Case Comprehensive Cancer Center | httpsreporternihgovquickSearchP30CA043703 |
| P30CA043703 | NIH | None | None |