Clinical trial · Observational
Depression, Cytokines and Pancreatic Cancer
NCT00582699CI-TRIAL-00014230completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| assessment interview and blood draw | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- label
- 1
- description
- Patients with pancreatic cancer who meet DSMIV criteria for a current diagnosis of a Major Depressive Episode (N=25).
- interventionNames
- Behavioral: assessment interview and blood draw
- label
- 2
- description
- Patients with pancreatic cancer who do not meet DSMIV criteria for a current diagnosis of Major Depressive Episode (N=25)
- interventionNames
- Behavioral: assessment interview and blood draw
- label
- 3
- description
- Healthy controls who meet DSMIV criteria for a current diagnosis of Major Depressive Episode (N=25).
- interventionNames
- Behavioral: assessment interview and blood draw
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: 1. 40 years of age or older at the time of recruitment. 2. Unresectable/inoperable pancreatic adenocarcinoma (stage III or IV), receiving Gemcitabine or Gemcitabine-based combination therapy. 3. 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. 4. 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. Exclusion Criteria: 1\. 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. 4\. 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 * Recent vaccination for viral disease * Major surgery within the past 6 weeks 5\. Patient Reports Receiving treatment (within two weeks) with: * Interleukin * Interferon * Thalidomide * NSAID's * Cox-2 inhibitors * Cancer vaccine therapies 6\. Self-reported diagnosis with a major psychiatric disorder other than depression (e.g. psychosis secondary to Bipolar Disorder, Schizophrenia, Schizo-affective illness, substance abuse) so severe that, in the opinion of the study staff, would interfere with a patient's ability to give informed consent for research. 7\. Cognitive impairment so severe that, in the opinion of the study staff, would interfere with a patient's ability to give informed consent or complete study measures for research.
References
Publications (0)
Data not yet available
No reference posted for this study.