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CompletedNCT02830620CHIMIOKINESUpdated Oct 26, 2022

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

An interventional study of Dosage of chimiokines in Cancer of the Pancreas and Anorexia, sponsored by Centre Hospitalier Universitaire de Nice. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-10-26.

Sponsored by Centre Hospitalier Universitaire de Nice · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Cancer of the Pancreas
  • Anorexia
03

In context

Pancreatic Neoplasms

3,235 studies on the registry are indexed under Pancreatic Neoplasms; 898 are open to participants now.

This study's enrollment of 40 is below the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.

Browse Pancreatic Neoplasms studies →

Lead sponsor

Centre Hospitalier Universitaire de Nice is the lead sponsor of 709 studies on the registry; 176 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Other
    groupe1

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

    Other: Dosage of chimiokines

  • Other
    groupe2

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

    Other: Dosage of chimiokines

  • Other
    groupe3

    pure food limitation typifies restrictive anorexia nervosa Dosage of chimiokines

    Other: Dosage of chimiokines

  • Other
    groupe4

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

    Other: Dosage of chimiokines

Interventions

  • OtherDosage of chimiokines
06

What researchers measure

Primary outcomes

  1. 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

    Time frame: change from baseline to 180 days

07

Study locations

1 site
  • CHU de Nice
    Nice, 06000, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 26, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02830620
Lead sponsor
Centre Hospitalier Universitaire de Nice
Responsible party
Sponsor
First posted
Jul 13, 2016
Start date
Aug 1, 2012
Primary completion
Dec 2, 2013
Completion
Dec 24, 2019
Last update
Oct 26, 2022

Study contacts

Stéphane SCHNEIDER, Pr
principal investigator · Centre Hospitalier Universitaire de Nice

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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