Exploring the Role of Serum Methylmalonic Acid (MMA) in Breast Cancer

NCT ID: NCT05352737

Last Updated: 2022-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-22

Study Completion Date

2022-06-24

Brief Summary

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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

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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

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Breast Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Pri-Meta

patients with breast cancer metastasis at first diagnosis

methylmalonic acid testing

Intervention Type DIAGNOSTIC_TEST

Sec-Meta

patients with early breast cancer developed distant metastasis within 5 years

methylmalonic acid testing

Intervention Type DIAGNOSTIC_TEST

Non-Meta

patients with early breast cancer did not develop distant metastasis within 5 years

methylmalonic acid testing

Intervention Type DIAGNOSTIC_TEST

older

patients with breast cancer older than 70 years old with G8 screening

methylmalonic acid testing

Intervention Type DIAGNOSTIC_TEST

pCR

patients with breast cancer reached pCR after neoadjuvant chemotherapy

methylmalonic acid testing

Intervention Type DIAGNOSTIC_TEST

non-pCR

patients with breast cancer did not reach pCR after neoadjuvant chemotherapy

methylmalonic acid testing

Intervention Type DIAGNOSTIC_TEST

Interventions

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methylmalonic acid testing

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

1. Female patients older than 18 years at diagnosis.
2. First diagnosis of invasive breast cancer.
3. All pathological parameters are available to identify histological subtype according to standard procedures.
4. Availability of frozen serum samples at diagnosis.
5. Voluntarily signed Informed Consent obtained before blood drawing for biobanking was performed.

Exclusion Criteria

1. Pregnant at diagnosis.
2. stage 0 disease (in situ).
3. Bilateral BC at diagnosis or multifocal unilateral BC with different histology.
4. Other subtypes than Invasive ductal carcinoma.
5. Prior breast cancer.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Qi Wu

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hans Wildiers, PhD

Role: PRINCIPAL_INVESTIGATOR

UZ Leuven

Locations

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Lab of Experimental Oncology

Leuven, State Or Province:, Belgium

Site Status

Countries

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Belgium

Other Identifiers

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S64752

Identifier Type: -

Identifier Source: org_study_id

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