Primary Prostate Urothelial CancerNCT06380062
Choline Metabolites in People With Prostate Cancer and Those With Benign Hyperplasia
An observational study of Primary Prostate Urothelial Cancer and Benign Prostatic Hyperplasia, run by Universität des Saarlandes at 1 site in Germany.
Trial summary
The aim of this study was to investigate plasma concentrations of one-carbon metabolites and phospholipid classes in participants with primary prostate cancer and those with benign hyperplasia. Moreover, the metabolites were studied in relation to tumor grade and age. Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Primary Prostate Urothelial Cancer, Benign Prostatic Hyperplasia
- What is being tested?
- Plasma concentration of choline
- How many people
- 350 participants
- Where
- 1 siteGermany
- Study dates
- 12 Jan 2012to 30 Nov 2015
- Phase
- Observational
- 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 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Participants were recruited before carrying out the radical prostatectomy surgery, or TURP surgery.
Who may be able to join
- Men participants
- age > 50 years
- recently diagnosed with primary prostate cancer or benign hyperplasia
Who cannot join
- vitamin B supplementation (folic acid> 400 µg / day; B12> 10 µg / day; B6> 10 mg / day)
- renal failure
- advanced liver disease
- chronic alcohol consumption
- metastases
- methotrexate therapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pre-operative Plasma Concentrations of Choline and Its Metabolites in People With Prostate Cancer Compared to Those With Benign Hyperplasia
The aim of this study was to investigate plasma concentrations of one-carbon metabolites and phospholipid classes in participants with primary prostate cancer and those with benign hyperplasia. Moreover, the metabolites were studied in relation to tumor grade and age.
Read the detailed description
This observational study recruited participants with primary prostate cancer (cases) and those with benign hyperplasia (controls) before the surgery. Data on the outcomes of the surgery including the results of the biopsy investigation were collected. Blood samples were collected before the surgery in context of routine blood investigations. Blood plasma samples collected on ethylenediaminetetraacetic acid (EDTA) were used to measure concentrations of free choline, betaine, dimethylglycine, folate forms, S-adenosylhomocysteine, S-adenosylmethionine, homocysteine, cystathionine, and methylmalonic acid (MMA). Data on serum concentrations of prostate specific antigen (PSA) and the tumor grade and classification (Gleason Score system) were collected. The associations between the plasma concentrations of the metabolites and PSA or the Gleason score were studied. The concentrations of the metabolic markers were compared between the cases and the controls according to the age of the participants.
- Being tested
- Plasma concentration of choline
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasma concentration of cholineOther
The exposure in this observational study is plasma concentrations of choline
| Study group | Role | What they receive |
|---|---|---|
| Primary prostate cancer | Men participants diagnosed with primary prostate cancer are "cases" Receives: Other: Plasma concentration of choline | |
| Benign hyperplasia | Men participants diagnosed with benign hyperplasia are the "controls" Receives: Other: Plasma concentration of choline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma choline concentrations
Concentrations measured in plasma with liquid chromatography tandem mass spectrometry
Measured: through study completion, on average 1 year
Whole blood choline concentrations
Concentrations measured in plasma with liquid chromatography tandem mass spectrometry
Measured: through study completion, on average 1 year
Secondary outcomes (6)
Plasma and whole blood folate forms
Concentrations measured in plasma with liquid chromatography tandem mass spectrometry
Measured: through study completion, on average 1 year
Plasma phospholipids
Concentrations measured in plasma with liquid chromatography tandem mass spectrometry after extraction
Measured: through study completion, on average 1 year
Plasma S-adenosylmethionine concentrations
Concentrations measured in plasma with liquid chromatography tandem mass spectrometry
Measured: through study completion, on average 1 year
Plasma betaine concentrations
Concentrations measured in plasma with liquid chromatography tandem mass spectrometry
Measured: through study completion, on average 1 year
Plasma methylmalonic acid concentrations
Concentrations measured in plasma with gas chromatography mass spectrometry
Measured: through study completion, on average 1 year
Plasma homocysteine concentrations
Concentrations measured in plasma with liquid chromatography tandem mass spectrometry
Measured: through study completion, on average 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2024
- Study start12 Jan 2012
- Primary completion30 Nov 2015
- Study completion30 Nov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Primary Prostate Urothelial CancerStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universität des Saarlandes
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rima Obeid, Universität des Saarlandes
- Investigators
- Rima Obeid, PhD, Principal investigator, Saarland University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06380062
- Sponsor's protocol ID
- Choline Prostate Cancer
- Status last verified
- Apr 2024
- First submitted
- 2 May 2023
- Last updated
- 25 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data available to other researchers. Only data in aggregated form can be provided upon reasonable request to the study PI.
Publications
Awwad HM, Ohlmann CH, Stoeckle M, Aziz R, Geisel J, Obeid R. Choline-phospholipids inter-conversion is altered in elderly patients with prostate cancer. Biochimie. 2016 Jul;126:108-14. doi: 10.1016/j.biochi.2016.01.003. Epub 2016 Jan 14.
PubMed 26776756Awwad HM, Ohlmann CH, Stoeckle M, Geisel J, Obeid R. Serum concentrations of folate vitamers in patients with a newly diagnosed prostate cancer or hyperplasia. Clin Biochem. 2018 Jun;56:41-46. doi: 10.1016/j.clinbiochem.2018.04.011. Epub 2018 Apr 16.
PubMed 29673813
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-operative Plasma Concentrations of Choline and Its Metabolites in People With Prostate Cancer Compared to Those With Benign Hyperplasia
- ClinicalTrials.gov ID
- NCT06380062
- Acronym / sponsor ID
- Choline Prostate Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Universität des SaarlandesUniversity, hospital or other
- Study start
- 12 Jan 2012 (actual)
- Primary completion
- 30 Nov 2015 (actual)
- Study completion
- 30 Nov 2015 (actual)
- First posted
- 23 Apr 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.
The aim of this study was to investigate plasma concentrations of one-carbon metabolites and phospholipid classes in participants with primary prostate cancer and those with benign hyperplasia. Moreover, the metabolites were studied in relation to tumor grade and age.
Detailed description
This observational study recruited participants with primary prostate cancer (cases) and those with benign hyperplasia (controls) before the surgery. Data on the outcomes of the surgery including the results of the biopsy investigation were collected. Blood samples were collected before the surgery in context of routine blood investigations. Blood plasma samples collected on ethylenediaminetetraacetic acid (EDTA) were used to measure concentrations of free choline, betaine, dimethylglycine, folate forms, S-adenosylhomocysteine, S-adenosylmethionine, homocysteine, cystathionine, and methylmalonic acid (MMA). Data on serum concentrations of prostate specific antigen (PSA) and the tumor grade and classification (Gleason Score system) were collected. The associations between the plasma concentrations of the metabolites and PSA or the Gleason score were studied. The concentrations of the metabolic markers were compared between the cases and the controls according to the age of the participants.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary prostate cancer | – | Other: Plasma concentration of cholineMen participants diagnosed with primary prostate cancer are "cases" |
| Benign hyperplasia | – | Other: Plasma concentration of cholineMen participants diagnosed with benign hyperplasia are the "controls" |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants were recruited before carrying out the radical prostatectomy surgery, or TURP surgery.
Key inclusion criteria (3 listed)
- Men participants
- age > 50 years
- recently diagnosed with primary prostate cancer or benign hyperplasia
Key exclusion criteria (6 listed)
- vitamin B supplementation (folic acid> 400 µg / day; B12> 10 µg / day; B6> 10 mg / day)
- renal failure
- advanced liver disease
- chronic alcohol consumption
- metastases
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 |
|---|---|---|
| Plasma concentration of cholineThe exposure in this observational study is plasma concentrations of choline | Other | Benign hyperplasia, Primary prostate cancer |
Primary outcome
Plasma choline concentrations
Time frame: through study completion, on average 1 year
Concentrations measured in plasma with liquid chromatography tandem mass spectrometry
Whole blood choline concentrations
Time frame: through study completion, on average 1 year
Concentrations measured in plasma with liquid chromatography tandem mass spectrometry
6 secondary outcomes
Plasma and whole blood folate forms
Time frame: through study completion, on average 1 year
Plasma phospholipids
Time frame: through study completion, on average 1 year
Plasma S-adenosylmethionine concentrations
Time frame: through study completion, on average 1 year
Plasma betaine concentrations
Time frame: through study completion, on average 1 year
Plasma methylmalonic acid concentrations
Time frame: through study completion, on average 1 year
Plasma homocysteine concentrations
Time frame: through study completion, on average 1 year
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 25 Apr 2024.
- Results publication: PubMed 26776756Awwad HM, Ohlmann CH, Stoeckle M, Aziz R, Geisel J, Obeid R. Choline-phospholipids inter-conversion is altered in elderly patients with prostate cancer. Biochimie. 2016 Jul;126:108-14. doi: 10.1016/j.biochi.2016.01.003. Epub 2016 Jan 14.
- Results publication: PubMed 29673813Awwad HM, Ohlmann CH, Stoeckle M, Geisel J, Obeid R. Serum concentrations of folate vitamers in patients with a newly diagnosed prostate cancer or hyperplasia. Clin Biochem. 2018 Jun;56:41-46. doi: 10.1016/j.clinbiochem.2018.04.011. Epub 2018 Apr 16.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data available to other researchers. Only data in aggregated form can be provided upon reasonable request to the study PI.
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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.
Rima Obeid, PhD principal investigator
Saarland University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Prostate Urothelial Cancer and Benign Prostatic Hyperplasia, run by Universität des Saarlandes at 1 site in Germany.
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 6 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 25 Apr 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 Germany. 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?
Plasma choline concentrations (time frame: through study completion, on average 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06380062, which also lists 2 linked publications.
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 25 Apr 2024.