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

Primary Purpose

Cancer of the Pancreas, Anorexia

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Dosage of chimiokines
Sponsored by
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Cancer of the Pancreas

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CHU de Nice

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

groupe1

groupe2

groupe3

groupe4

Arm Description

cancer of the pancreas WITH syndrome of anorexia-cachexie Dosage of chimiokines

cancer of the pancreas WITHOUT syndrome of anorexia-cachexie Dosage of chimiokines

pure food limitation typifies restrictive anorexia nervosa Dosage of chimiokines

unhurt individual of any appetite-suppressing evolutionary disease and cachectisante Dosage of chimiokines

Outcomes

Primary Outcome Measures

chimiokine MCP1 expression
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

Secondary Outcome Measures

Full Information

First Posted
July 20, 2012
Last Updated
October 24, 2022
Sponsor
Centre Hospitalier Universitaire de Nice
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1. Study Identification

Unique Protocol Identification Number
NCT02830620
Brief Title
Study at the Man of the Profile of Chimiokines in the Anorexia Bound to the Cancerous Cachexy
Acronym
CHIMIOKINES
Official Title
Study at the Man of the Profile of Chimiokines in the Anorexia Bound to the Cancerous Cachexy.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
August 1, 2012 (Actual)
Primary Completion Date
December 2, 2013 (Actual)
Study Completion Date
December 24, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer of the Pancreas, Anorexia

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
groupe1
Arm Type
Other
Arm Description
cancer of the pancreas WITH syndrome of anorexia-cachexie Dosage of chimiokines
Arm Title
groupe2
Arm Type
Other
Arm Description
cancer of the pancreas WITHOUT syndrome of anorexia-cachexie Dosage of chimiokines
Arm Title
groupe3
Arm Type
Other
Arm Description
pure food limitation typifies restrictive anorexia nervosa Dosage of chimiokines
Arm Title
groupe4
Arm Type
Other
Arm Description
unhurt individual of any appetite-suppressing evolutionary disease and cachectisante Dosage of chimiokines
Intervention Type
Other
Intervention Name(s)
Dosage of chimiokines
Primary Outcome Measure Information:
Title
chimiokine MCP1 expression
Description
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
Time Frame
change from baseline to 180 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stéphane SCHNEIDER, Pr
Organizational Affiliation
Centre Hospitalier Universitaire de Nice
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Nice
City
Nice
ZIP/Postal Code
06000
Country
France

12. IPD Sharing Statement

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

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