Cancer of the PancreasCHIMIOKINESNCT02830620
Study at the Man of the Profile of Chimiokines in the Anorexia Bound to the Cancerous Cachexy
A study testing Dosage of chimiokines in people with Cancer of the Pancreas and Anorexia, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer of the Pancreas, Anorexia
- What is being tested?
- Dosage of chimiokines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 1 Aug 2012to 24 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Patient to hospitalize in the(unit) of digestive cancer research.
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- 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.
- 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.
- 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.
Who cannot join
- 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}
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- 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}
- 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}
- Patient refusing to participate in the study
- Under guardianship patient or guardianship.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study at the Man of the Profile of Chimiokines in the Anorexia Bound to the Cancerous Cachexy.
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.
- Conditions
- Cancer of the Pancreas, Anorexia
- Being tested
- Dosage of chimiokines
- Medical subject headings
- Pancreatic Neoplasms, Anorexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dosage of chimiokinesOther
| Study group | Role | What they receive |
|---|---|---|
| groupe1 | Other | cancer of the pancreas WITH syndrome of anorexia-cachexie Dosage of chimiokines Receives: Other: Dosage of chimiokines |
| groupe2 | Other | cancer of the pancreas WITHOUT syndrome of anorexia-cachexie Dosage of chimiokines Receives: Other: Dosage of chimiokines |
| groupe3 | Other | pure food limitation typifies restrictive anorexia nervosa Dosage of chimiokines Receives: Other: Dosage of chimiokines |
| groupe4 | Other | unhurt individual of any appetite-suppressing evolutionary disease and cachectisante Dosage of chimiokines Receives: Other: Dosage of chimiokines |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: change from baseline to 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2016 (estimated)
- Study start1 Aug 2012
- Primary completion2 Dec 2013
- Study completion24 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of the PancreasStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stéphane SCHNEIDER, Pr, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02830620
- Sponsor's protocol ID
- 12-PP-03
- Acronym
- CHIMIOKINES
- Status last verified
- Oct 2022
- First submitted
- 20 Jul 2012
- Last updated
- 26 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study at the Man of the Profile of Chimiokines in the Anorexia Bound to the Cancerous Cachexy.
- ClinicalTrials.gov ID
- NCT02830620
- Acronym / sponsor ID
- CHIMIOKINES / 12-PP-03
- Conditions
- Cancer of the Pancreas, Anorexia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 1 Aug 2012 (actual)
- Primary completion
- 2 Dec 2013 (actual)
- Study completion
- 24 Dec 2019 (actual)
- First posted
- 13 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| groupe1 | Other | Other: Dosage of chimiokinescancer of the pancreas WITH syndrome of anorexia-cachexie Dosage of chimiokines |
| groupe2 | Other | Other: Dosage of chimiokinescancer of the pancreas WITHOUT syndrome of anorexia-cachexie Dosage of chimiokines |
| groupe3 | Other | Other: Dosage of chimiokinespure food limitation typifies restrictive anorexia nervosa Dosage of chimiokines |
| groupe4 | Other | Other: Dosage of chimiokinesunhurt individual of any appetite-suppressing evolutionary disease and cachectisante Dosage of chimiokines |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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.
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dosage of chimiokines | Other | groupe1, groupe2, groupe3, groupe4 |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stéphane SCHNEIDER, Pr principal investigator
Centre Hospitalier Universitaire de Nice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dosage of chimiokines in people with Cancer of the Pancreas and Anorexia, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
chimiokine MCP1 expression (time frame: change from baseline to 180 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2022.