Depression, Cytokines and Pancreatic Cancer

NCT00582699 | Completed

• 2 other identifiers: 05-117NIH CA102201
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to measure certain specific chemicals in your blood, produced by the body in response to a stress, such as having pancreatic cancer. These chemicals are called "cytokines" and the researchers doing this study want to look at the role they may play in developing depression.

Conditions

Pancreatic Cancer

Keywords

Pancreatic Cancer; Pancreatic

Outcome Measures

Primary Outcomes (1)

• The levels of specific cytokines (IL-1, Il-6, TNF-alpha, as well as IL-10, Il-15 and IFN-gamma), the diagnosis of Depression, depressive symptom severity, and the pattern of depressive symptoms.

  November 2010

Study Arms (4)

1

Patients with pancreatic cancer who meet DSMIV criteria for a current diagnosis of a Major Depressive Episode (N=25).

Behavioral: assessment interview and blood draw

2

Patients with pancreatic cancer who do not meet DSMIV criteria for a current diagnosis of Major Depressive Episode (N=25)

Behavioral: assessment interview and blood draw

3

Healthy controls who meet DSMIV criteria for a current diagnosis of Major Depressive Episode (N=25).

Behavioral: assessment interview and blood draw

4

Healthy controls who do not meet DSMIV criteria for a current diagnosis of Major Depressive Episode (N=25).

Behavioral: assessment interview and blood draw

Interventions

assessment interview and blood draw BEHAVIORAL

All subjects will be administered a battery of clinician rated and self report instruments including measures of depression, fatigue, and cognitive functioning. In addition, measures of pain, sleep, and anxiety will also be utilized to assess these important potential confounding variables. The SCIDIV will be used to ascertain the presence or absence of a current DSMIV diagnosis of Major Depressive Episode for all subjects. The interview should take approximately fortyfive minutes to complete. Patients will have their blood drawn once, in order to determine plasma levels of the cytokines IL1, IL6, TNFalpha, IL10, IL15 and IFNgamma.

1; 2; 3; 4

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Recruitment of patients will take place primarily in the Ambulatory Care Facility on 53rd street in the GI Oncology Clinic treating pancreatic cancer. Healthy control subjects with depression will be recruited from the New York Hospital Payne Whitney Clinic outpatient facilities and MSKCC. Healthy control subjects without depression will be recruited from contacts supplied by study participants (e.g. spouses, relatives and friends) and from Memorial Hospital staff volunteers.

You may qualify if:

• years of age or older at the time of recruitment.
• Unresectable/inoperable pancreatic adenocarcinoma (stage III or IV), receiving Gemcitabine or Gemcitabine-based combination therapy.
• If in the "depressed" sample, patients with pancreatic cancer must meet DSM-IV criteria for a major depressive syndrome (based on the SCID) AND have an HDRS score of 18 or greater.
• If in the "non-depressed" sample, patients with pancreatic cancer must not meet DSM-IV criteria for a major depressive syndrome (based on the SCID) AND must have a HDRS score of 17 or less.

You may not qualify if:

• \. A. Patient has reported experiencing or medical record indicates a serious medical event (i.e.,medical hospitalization (excluding hospitalization related to cancer diagnosis/treatment),myocardial infarction, stroke) within the year preceding study participation.
• B. Patient has reported the presence of or medical record indicates:
• Type 1 Diabetes, unrelated to cancer diagnosis
• renal failure requiring dialysis
• inflammatory bowel disease 3. Patient has reported the presence of or medical record indicates an active secondary cancer diagnosis, however patients who have been treated for a past cancer and are 2 years disease free from that cancer can participate.
• \. Presence of a medical/surgical condition obtained through self-report associated with elevated cytokine levels, such as:
• HIV/AIDS
• Auto-immune diseases such as SLE, Multiple Sclerosis, Rheumatoid Arthritis, Polymyalgia Rheumatica, Temporal Arteritis, Chronic Fatigue Syndrome, severe allergies
• Congestive Heart Failure
• Recent stroke
• Alzheimer's Disease
• Active infection;
• Acute pancreatitis
• Acute pericarditis
• Acute hepatitis including Hepatitis C

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Institutes of Health (NIH): collaborator
• New York Presbyterian Hospital: collaborator

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan-Kettering Cancer Center website

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Williams Breitbart, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: December 28, 2007
• Study Start: November 1, 2005
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: April 10, 2014

Record last verified: 2014-04

Locations

US (1)