Breast CancerNCT05352737
Exploring the Role of Serum Methylmalonic Acid (MMA) in Breast Cancer
An observational study of Breast Cancer, run by KU Leuven at 1 site in Belgium.
Trial summary
This project aims to investigate the role of MMA in breast cancer. To this end, we will measure MMA on serum samples collected at the time of breast cancer diagnosis, to investigate the role of MMA in predicting long-term recurrence risk, response to neoadjuvant chemotherapy, and its association with age and clinical… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- methylmalonic acid testing
- How many people
- 300 participants
- Where
- 1 siteBelgium
- Study dates
- 22 Jan 2021to 24 Jun 2022
- 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 18 years and older
- Women only
- Adult, Older adult
Study population: patients with breast cancer admitted into University of Hospital, Leuven, from 2003 to 2015.
Who may be able to join
- Female patients older than 18 years at diagnosis.
- First diagnosis of invasive breast cancer.
- All pathological parameters are available to identify histological subtype according to standard procedures.
- Availability of frozen serum samples at diagnosis.
- Voluntarily signed Informed Consent obtained before blood drawing for biobanking was performed.
Who cannot join
- Pregnant at diagnosis.
- stage 0 disease (in situ).
- Bilateral BC at diagnosis or multifocal unilateral BC with different histology.
- Other subtypes than Invasive ductal carcinoma.
- Prior breast cancer.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Retrospective Study Exploring the Role of Serum Methylmalonic Acid (MMA) in Breast Cancer---focusing on Metastasis, Chemotherapy Resistance, and Ageing Effects
This project aims to investigate the role of MMA in breast cancer. To this end, we will measure MMA on serum samples collected at the time of breast cancer diagnosis, to investigate the role of MMA in predicting long-term recurrence risk, response to neoadjuvant chemotherapy, and its association with age and clinical frailty.
Read the detailed description
This project aims to investigate the role of MMA in breast cancer. To this end, we will measure MMA on serum samples collected at the time of breast cancer diagnosis, to investigate the role of MMA in predicting long-term recurrence risk, response to neoadjuvant chemotherapy, and its association with age and clinical frailty. If the role of baseline serum MMA in therapy resistance and/or metastasis is confirmed, our study could be further extended by evaluating SOX4 expression in the tumor tissues (SOX4 is activated by MMA, and SOX4 induces EMT (epithelial to mesenchymal transition) and the metastasis process.
- Conditions
- Breast Cancer
- Being tested
- methylmalonic acid testing
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
methylmalonic acid testingDiagnostic test
| Study group | Role | What they receive |
|---|---|---|
| Pri-Meta | patients with breast cancer metastasis at first diagnosis Receives: Diagnostic Test: methylmalonic acid testing | |
| Sec-Meta | patients with early breast cancer developed distant metastasis within 5 years Receives: Diagnostic Test: methylmalonic acid testing | |
| Non-Meta | patients with early breast cancer did not develop distant metastasis within 5 years Receives: Diagnostic Test: methylmalonic acid testing | |
| older | patients with breast cancer older than 70 years old with G8 screening Receives: Diagnostic Test: methylmalonic acid testing | |
| pCR | patients with breast cancer reached pCR after neoadjuvant chemotherapy Receives: Diagnostic Test: methylmalonic acid testing | |
| non-pCR | patients with breast cancer did not reach pCR after neoadjuvant chemotherapy Receives: Diagnostic Test: methylmalonic acid testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
MMA levels
baseline serum MMA levels in pre-defined patients
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study start22 Jan 2021
- Primary completion24 Jun 2022
- Study completion24 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qi Wu, KU Leuven
- Investigators
- Hans Wildiers, PhD, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05352737
- Sponsor's protocol ID
- S64752
- Status last verified
- Jul 2022
- First submitted
- 22 Apr 2022
- Last updated
- 22 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Study Exploring the Role of Serum Methylmalonic Acid (MMA) in Breast Cancer---focusing on Metastasis, Chemotherapy Resistance, and Ageing Effects
- ClinicalTrials.gov ID
- NCT05352737
- Acronym / sponsor ID
- S64752
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- 22 Jan 2021 (actual)
- Primary completion
- 24 Jun 2022 (actual)
- Study completion
- 24 Jun 2022 (actual)
- First posted
- 29 Apr 2022 (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.
This project aims to investigate the role of MMA in breast cancer. To this end, we will measure MMA on serum samples collected at the time of breast cancer diagnosis, to investigate the role of MMA in predicting long-term recurrence risk, response to neoadjuvant chemotherapy, and its association with age and clinical frailty.
Detailed description
This project aims to investigate the role of MMA in breast cancer. To this end, we will measure MMA on serum samples collected at the time of breast cancer diagnosis, to investigate the role of MMA in predicting long-term recurrence risk, response to neoadjuvant chemotherapy, and its association with age and clinical frailty. If the role of baseline serum MMA in therapy resistance and/or metastasis is confirmed, our study could be further extended by evaluating SOX4 expression in the tumor tissues (SOX4 is activated by MMA, and SOX4 induces EMT (epithelial to mesenchymal transition) and the metastasis process.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Pri-Meta | – | Diagnostic Test: methylmalonic acid testingpatients with breast cancer metastasis at first diagnosis |
| Sec-Meta | – | Diagnostic Test: methylmalonic acid testingpatients with early breast cancer developed distant metastasis within 5 years |
| Non-Meta | – | Diagnostic Test: methylmalonic acid testingpatients with early breast cancer did not develop distant metastasis within 5 years |
| older | – | Diagnostic Test: methylmalonic acid testingpatients with breast cancer older than 70 years old with G8 screening |
| pCR | – | Diagnostic Test: methylmalonic acid testingpatients with breast cancer reached pCR after neoadjuvant chemotherapy |
| non-pCR | – | Diagnostic Test: methylmalonic acid testingpatients with breast cancer did not reach pCR after neoadjuvant chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- patients with breast cancer admitted into University of Hospital, Leuven, from 2003 to 2015.
Key inclusion criteria (5 listed)
- Female patients older than 18 years at diagnosis.
- First diagnosis of invasive breast cancer.
- All pathological parameters are available to identify histological subtype according to standard procedures.
- Availability of frozen serum samples at diagnosis.
- Voluntarily signed Informed Consent obtained before blood drawing for biobanking was performed.
Key exclusion criteria (5 listed)
- Pregnant at diagnosis.
- stage 0 disease (in situ).
- Bilateral BC at diagnosis or multifocal unilateral BC with different histology.
- Other subtypes than Invasive ductal carcinoma.
- Prior breast cancer.
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 |
|---|---|---|
| methylmalonic acid testing | Diagnostic test | Non-Meta, Pri-Meta, Sec-Meta, non-pCR, older, pCR |
Primary outcome
MMA levels
Time frame: baseline
baseline serum MMA levels in pre-defined patients
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 22 Jul 2022.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Hans Wildiers, PhD principal investigator
UZ Leuven
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 Breast Cancer, run by KU Leuven at 1 site in Belgium.
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 5 inclusion and 5 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 22 Jul 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 Belgium. 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?
MMA levels (time frame: baseline). 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 22 Jul 2022.