Ovarian CancerAMINOCANCERNCT06216496
Evaluation of Amino Acid Metabolism Changes in Ovarian Cancer
A study testing dynamic test for amino acid metabolism in people with Ovarian Cancer, run by University Hospital, Grenoble at 1 site in France.
Trial summary
Ovarian cancer is associated with undernutrition in more than half of all cases. The current management of undernutrition-cachexia in cancer is not specific. It is well recognized that the nutritional support currently offered to cancer patients is not effective in combating cachexia, which progresses inexorably… Read more about this study
- Who is it for?
- Ages 40 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- dynamic test for amino acid metabolism
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteFrance
- Study dates
- 11 Mar 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Histological diagnosis of high-grade serous ovarian cancer not immediately resectable (stage III or IVa) managed at Grenoble Alpes University Hospital.
- Affiliation to the French social security system.
- Able to understand and follow the instructions necessary for the conduct of the trial, and having given written consent for the study.
Who cannot join
- Significant active comorbidity requiring long-term drug treatment (e.g. organ failure, diabetes) or history of pathology likely to impact amino acid metabolism (e.g. urea or homocysteine cycle abnormalities, tyrosinemia, alkaptonuria, hyperprolinemia, organic aciduria).
- vegetarian or vegan diet
- difficult venous access
- Persons covered by articles L1121-5 to L1121-8 of the CSP (corresponding to all protected persons: pregnant women, parturients, nursing mothers, persons deprived of their liberty by judicial or administrative decision, persons subject to a legal protection measure).
- Subject receiving more than 4,500 euros in compensation for participation in other research involving the human body in the 12 months preceding this study.
- Significant biological abnormalities (not explained by the underlying pathology for women with ovarian cancer)
- Liver metastases
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Grenoble Alpes
La Tronche
Cécile Bétry, 04 76 76 75 75, cbetry@chu-grenoble.fr
About this study
Official title: Evaluation of Amino Acid Metabolism Changes in Participants With Ovarian Cancer by Dynamic Test
Ovarian cancer is associated with undernutrition in more than half of all cases. The current management of undernutrition-cachexia in cancer is not specific. It is well recognized that the nutritional support currently offered to cancer patients is not effective in combating cachexia, which progresses inexorably, leading to the patient's death. It is therefore necessary to offer specific and adapted care, in particular by optimizing the quality of nitrogen intake. To achieve this, the investigators first need to define the specific amino acid requirements of cancer patients.
- Conditions
- Ovarian Cancer
- Being tested
- dynamic test for amino acid metabolism
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dynamic test for amino acid metabolismOther
Subjects are fasting, and the dynamic test is performed as follows:
Placement of 1 peripheral venous line (for infusions).
- H0-H1.5: infusion of a 10% glucose solution at increasing flow rate (3 steps of 30 min each: 0.06g/kg/h then 0.12g/kg/h then 0.25g/kg/h of glucose)
- H1,5: initial blood sampling (amino acid assay)
- H1.5-H4.5: infusion of amino acid solution (Aminoven 5%, Fresenius Kabi, Sèvres, France) at constant speed (flow rate 10.5 mg/kg/h of nitrogen or 1.30 ml/kg/H) in Y with glucose infusion (0.25g/kg/h of glucose)
- H4.5: Final blood sampling (amino acid assay) Each amino acid is plotted as a function of its perfusion rate on the abscissa and its variation in plasma concentration on the ordinate.
| Study group | Role | What they receive |
|---|---|---|
| Dynamic test | Experimental | Not described Receives: Other: dynamic test for amino acid metabolism |
What is being measured
The primary outcome is the main question the study is designed to answer.
metabolism of each amino acid, in women with non-immediately resectable ovarian cancer (with or without peritoneal metastases) of high-grade serous type.
degree of consumption of each amino acid estimated by the difference in plasma concentration in µmol/L measured after 90 minutes (H 1.5) and 270 minutes (H 4.5) of perfusion.
Measured: 270 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start11 Mar 2024
- Primary completionApr 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06216496
- Sponsor's protocol ID
- 38RC20.038
- Other IDs
- 2022-A01369-34
- Acronym
- AMINOCANCER
- Status last verified
- Dec 2023
- First submitted
- 26 Dec 2023
- Last updated
- 20 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Amino Acid Metabolism Changes in Participants With Ovarian Cancer by Dynamic Test
- ClinicalTrials.gov ID
- NCT06216496
- Acronym / sponsor ID
- AMINOCANCER / 38RC20.038
- Conditions
- Ovarian Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 11 Mar 2024 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 22 Jan 2024 (actual)
- 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.
Ovarian cancer is associated with undernutrition in more than half of all cases. The current management of undernutrition-cachexia in cancer is not specific. It is well recognized that the nutritional support currently offered to cancer patients is not effective in combating cachexia, which progresses inexorably, leading to the patient's death. It is therefore necessary to offer specific and adapted care, in particular by optimizing the quality of nitrogen intake. To achieve this, the investigators first need to define the specific amino acid requirements of cancer patients.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dynamic test | Experimental | Other: dynamic test for amino acid metabolism |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Histological diagnosis of high-grade serous ovarian cancer not immediately resectable (stage III or IVa) managed at Grenoble Alpes University Hospital.
- Affiliation to the French social security system.
- Able to understand and follow the instructions necessary for the conduct of the trial, and having given written consent for the study.
Key exclusion criteria (7 listed)
- Significant active comorbidity requiring long-term drug treatment (e.g. organ failure, diabetes) or history of pathology likely to impact amino acid metabolism (e.g. urea or homocysteine cycle abnormalities, tyrosinemia, alkaptonuria, hyperprolinemia, organic aciduria).
- vegetarian or vegan diet
- difficult venous access
- Persons covered by articles L1121-5 to L1121-8 of the CSP (corresponding to all protected persons: pregnant women, parturients, nursing mothers, persons deprived of their liberty by judicial or administrative decision, persons subject to a legal protection measure).
- Subject receiving more than 4,500 euros in compensation for participation in other research involving the human body in the 12 months preceding this study.
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 |
|---|---|---|
| dynamic test for amino acid metabolismSubjects are fasting, and the dynamic test is performed as follows: Placement of 1 peripheral venous line (for infusions). * H0-H1.5: infusion of a 10% glucose solution at increasing flow rate (3 steps of 30 min each: 0.06g/kg/h then 0.12g/kg/h then 0.25g/kg/h of glucose) * H1,5: initial blood sampling (amino acid assay) * H1.5-H4.5: infusion of amino acid solution (Aminoven 5%, Fresenius Kabi, Sèvres, France) at constant speed (flow rate 10.5 mg/kg/h of nitrogen or 1.30 ml/kg/H) in Y with glucose infusion (0.25g/kg/h of glucose) * H4.5: Final blood sampling (amino acid assay) Each amino acid is plotted as a function of its perfusion rate on the abscissa and its variation in plasma concentration on the ordinate. | Other | Dynamic test |
Primary outcome
metabolism of each amino acid, in women with non-immediately resectable ovarian cancer (with or without peritoneal metastases) of high-grade serous type.
Time frame: 270 minutes
degree of consumption of each amino acid estimated by the difference in plasma concentration in µmol/L measured after 90 minutes (H 1.5) and 270 minutes (H 4.5) of perfusion.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2024.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dynamic test for amino acid metabolism in people with Ovarian Cancer, run by University Hospital, Grenoble 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 3 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 20 May 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
metabolism of each amino acid, in women with non-immediately resectable ovarian cancer (with or without peritoneal metastases) of high-grade serous type. (time frame: 270 minutes). 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 20 May 2024.