Ghrelin Levels in Pancreatic Cancer Patients

Pancreatic Cancer Clinical Trial

Official title:

Assessment of Plasma Ghrelin Levels in Patients With Pancreatic Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00225745
• Other study ID #: DMS 0405
• Status: Completed
• Phase: N/A
• First received: September 22, 2005
• Last updated: October 12, 2015
• Start date: April 2004
• Est. completion date: September 2015

Study information

• Verified date: August 2015
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: September 2015
• Est. primary completion date: October 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Procedure:
• Blood draw
One blood draw prior to first treatment

Locations

Country	Name	City	State
United States	Dartmouth Hitchcock Medical Center/Norris Cotton Cancer Center	Lebanon	New Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate plasma ghrelin levels in patients with pancreatic cancer and compare with age matched controls		prior to treatment	No
Secondary	To investigate the role of ghrelin in pathophysiology of cancer cachexia		prior to treatment	Yes
Secondary	To generate hypotheses for future studies and treatment based on the findings		prior to treatment	No