Ghrelin Levels in Pancreatic Cancer Patients | NCT00225745

Studies
Ghrelin Levels in Pancreatic Cancer Patients

NCT00225745

Sponsor

Dartmouth-Hitchcock Medical Center

Status

Completed

Last Update Posted

Oct 14, 2015Estimated

Enrollment

72Actual

Phase

Not provided

Conditions

Pancreatic Cancer

Interventions

Blood draw

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2004

Primary Completion Date

Oct 2013Actual

Completion Date

Sep 2015Actual

First Submitted Date

Sep 22, 2005

First Submission Date that Met QC Criteria

Sep 22, 2005

First Posted Date

Sep 26, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 12, 2015

Last Update Posted Date

Oct 14, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The primary outcome measure for this study is plasma ghrelin level.

Detailed Description

The primary outcome measure for this study is plasma ghrelin level, and the two primary comparison are:

Patients with cachexia versus patients without cachexia
Patients with cachexia versus healthy controls

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

72Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Pancreatic cancer patients	Procedure: Blood draw
2		Healthy controls	Procedure: Blood draw

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Blood draw	Procedure	One blood draw prior to first treatment	1 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To evaluate plasma ghrelin levels in patients with pancreatic cancer and compare with age matched controls		prior to treatment

Secondary Outcomes

Measure	Description	Time Frame
To investigate the role of ghrelin in pathophysiology of cancer cachexia		prior to treatment
To generate hypotheses for future studies and treatment based on the findings		prior to treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histological or cytological proof of pancreatic adenocarcinoma
The control are will include healthy age-matched patients without cancer
The test arm will include patients with pancreatic cancer and they will divided into two groups: those with and without weight loss
Patients must have recovered from any major infections and/or surgical procedures

Exclusion Criteria:

Patients with other serious medical illness like congestive heart failure, thyroid disease,liver disease or renal failure - conditions that will alter their nutritional state
Patients on appetite stimulant and those receiving total parenteral nutrition
Patients who have undergone gastrectomy or those who have gastric ulcers
Patients receiving active chemotherapy
No prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer or for which patient has been disease free for at least five years.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Pancreatic cancer patients who have not received treatment. Healthy age-matched controls.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
J Marc Pipas, MD	Dartmouth-Hitchcock Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dartmouth Hitchcock Medical Center/Norris Cotton Cancer Center		Lebanon	New Hampshire	03756	United States

Condition Browse Module

MeSH Terms

ID	Term
D010190	Pancreatic Neoplasms

Ancestor Terms

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004701	Endocrine Gland Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001800	Blood Specimen Collection

Ancestor Terms

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided