Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study at the Man of the Profile of Chimiokines in the Anorexia Bound to the Cancerous Cachexy (CHIMIOKINES)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02830620
Recruitment Status : Unknown
Verified July 2016 by Centre Hospitalier Universitaire de Nice.
Recruitment status was:  Recruiting
First Posted : July 13, 2016
Last Update Posted : July 13, 2016
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

Brief Summary:

The syndrome of anorexia-cachexie, which accompanies numerous cancers is a major comorbidity which compromises the forecast of these patients. Several cytokines pro-inflammatory as interleukines IL1 ß, IL6 or TNFa participate in the physiopathology of this syndrome at the man and the animal. Besides, it is now established that different neuronal populations, localized in the hypothalamus, are nerve centers of the control of the appetite and the energy homéostasie. However, there is not enough evidence of a direct action of cytokines on these neurones, suggesting the participation of intermediate molecules as chimiokines, inflammatory molecules produced in reaction to an immunological stress by gliales cells and acting directly on the surrounding neurones. The implication of chimiokines in the syndrome of anorexia-cachexie associated with the cancer thus seems very likely Among these, chimiokines " Monocyte Chemoattractant Proteins 1-3 " or MCPs represent obvious candidates because they are produced by multiple tumors. Furthermore, to the mouse, the intellectual expression of MCP1 is correlated in the anorexia led by peripheral injections of a bacterial by-product, the lipopolysaccharide (LPS).

The investigators' main objective is to test at the Man's, in situation of cancer of the pancreas any confused stages, the degree of prédictivité of the chimiokine MCP1 towards the syndrome of anorexia-cachexie associated with the cancer. The investigator also suggest describing: i) the link between rate plasmatique of MCP1 and energy metabolism on one hand, physical composition on the other hand;; ii) the impact of the other chimiokines, particularly those of the family of the MCPs, on the anorexia-cachexie bound to the cancer, iii) the correlation enters their profile of expression plasmatique and the severity of the anorexia, the energy metabolism and the physical composition; iv) the same research on the other inflammatory factors plasmatiques, of nature different from chimiokines; v) the correlation between thin mass and anorexia; vi) the evolution of the chimiokines various and inflammatory factors after surgical treatment or chemotherapy with curative aim in 6 months.


Condition or disease Intervention/treatment Phase
Cancer of the Pancreas Anorexia Other: Dosage of chimiokines Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Study at the Man of the Profile of Chimiokines in the Anorexia Bound to the Cancerous Cachexy.
Study Start Date : August 2012
Actual Primary Completion Date : December 2013
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
groupe1
cancer of the pancreas WITH syndrome of anorexia-cachexie Dosage of chimiokines
Other: Dosage of chimiokines
groupe2
cancer of the pancreas WITHOUT syndrome of anorexia-cachexie Dosage of chimiokines
Other: Dosage of chimiokines
groupe3
pure food limitation typifies restrictive anorexia nervosa Dosage of chimiokines
Other: Dosage of chimiokines
groupe4
unhurt individual of any appetite-suppressing evolutionary disease and cachectisante Dosage of chimiokines
Other: Dosage of chimiokines



Primary Outcome Measures :
  1. chimiokine MCP1 expression [ Time Frame: change from baseline to 180 days ]
    Study at the Man's, in situation of cancer of the pancreas, diagnosed of novo and any confused stages, the prediction of the chimiokine MCP1 towards the syndrome of anorexia-cachexie associated with the cancer



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Group 1 {cancer of the pancreas WITH syndrome of anorexia-cachexie}

Inclusion Criteria:

  • Patient to hospitalize in the unit of digestive cancer research.
  • Patient ≥ 18 years.
  • Patient carrier of an adénocarcinome of the pancreas of novo, any stadium confused, diagnosed by imaging and/or histology.
  • Existence of at least one of the criteria following to hold(retain) the diagnosis of cachexie cancer patient: not deliberate loss of weight > in 5 % over the last 6 months OR(WHERE) IMC(CEREBRAL-MOTOR HANDICAPPED) < 20 kg / m ² with a loss of minimum weight > 2 % OR(WHERE) scrawny muscular index appendiculaire respectively < 7,26 kg / m ² at the man and < 5,45 kg / m ² at the woman with a minimal weight loss > 2 %.
  • Patient having signed the enlightened consent.

Exclusion Criteria:

  • Patient having a tumor other one than the pancreatic adénocarcinome.
  • Patient having a second offense of adénocarcinome pancreatic.
  • Patient carrier of a pancreatic adénocarcinome in the course of a treatment by chemotherapy.
  • Patient having a severe psychiatric comorbidity except TCA who can be responsible for food disorders.
  • Patient carrier of an evolutionary inflammatory disease other one than the cancer being able to interfere on the inflammatory status.

Groupe 2 {cancer du pancréas SANS syndrome d'anorexie-cachexie}

Inclusion Criteria:

  • Patient to hospitalize in the(unit) of digestive cancer research.
  • Patient ≥ 18 years.
  • Patient carrier of an adénocarcinome of the pancreas of novo, any stadium confused, diagnosed by imaging and/or histology.
  • Patient having signed a enlightened consent.

Exclusion Criteria:

  • Patient having a tumor other one than the pancreatic adénocarcinome.
  • Patient having a second offense(recurrence) of adénocarcinome pancreatic.
  • Patient carrier of a pancreatic adénocarcinome in the course of a treatment by chemotherapy.
  • Existence of at least one of the criteria in favour of the diagnosis of cachexie cancer patient: not deliberate loss of weight > in 5 % over the last 6 months OR(WHERE) IMC(CEREBRAL-MOTOR HANDICAPPED) < 20 kg / m ² with a loss of minimum weight > 2 % OR(WHERE) scrawny muscular index appendiculaire respectively < 7,26 kg / m ² at the man and < 5,45 kg / m ² at the woman with a minimal weight loss > 2 %.
  • Patient having a severe psychiatric comorbidity except TCA who can be responsible for food disorders.
  • Patient carrier of an evolutionary inflammatory disease other one than the cancer being able to interfere on the inflammatory status.
  • Patient refusing to participate in the study
  • Under guardianship patient or guardianship.

Group 3 {pure food limitation typifies restrictive anorexia nervosa}

Inclusion Criteria:

  • Patient seen in consultation in the unit of nutritional support(medium)
  • Patient ≥ 18 years.
  • Patient carrier of an eating disorder of type pure restrictive anorexia nervosa (according to criterion diagnosis of the WHO)
  • Patient having signed a enlightened consent.

Exclusion Criteria:

  • Patient having any evolutionary organic pathology source of a decrease of the oral contributions and/or the interference on the inflammatory status, and responsible for a loss of weight
  • Patient refusing to participate in the study
  • Under guardianship patient or guardianship.

Group 4 {unhurt individual of any appetite-suppressing evolutionary disease and cachectisante}

Inclusion Criteria:

  • Patient seen in consultation of hepatogastroenterology
  • Patient ≥ 18 years.
  • Unhurt patient of any organic or psychic, evolutionary pathology, cachectisante
  • Patient having signed a enlightened consent.

Exclusion Criteria:

  • Patient refusing to participate in the study
  • Under guardianship patient or guardianship.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02830620


Contacts
Layout table for location contacts
Contact: Stéphane SCHNEIDER, Pr 04.92.03.59.23 schneider.s@chu-nice.fr

Locations
Layout table for location information
France
CHU de Nice Recruiting
Nice, France, 06000
Contact: Sthéphane SCHNEIDER, Pr    04.92.03.59.23    schneider.s@chu-nice.fr   
Principal Investigator: Stéphane SCNEIDER, Pr         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
Layout table for investigator information
Principal Investigator: Stéphane SCHNEIDER, Pr Centre Hospitalier Universitaire de Nice

Layout table for additonal information
Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT02830620    
Other Study ID Numbers: 12-PP-03
First Posted: July 13, 2016    Key Record Dates
Last Update Posted: July 13, 2016
Last Verified: July 2016
Additional relevant MeSH terms:
Layout table for MeSH terms
Pancreatic Neoplasms
Anorexia
Signs and Symptoms, Digestive
Signs and Symptoms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases