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

Completed

• Conditions: Breast Cancer
• Interventions: Diagnostic Test: methylmalonic acid testing

• Registration Number: NCT05352737
• Lead Sponsor: KU Leuven

Brief 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 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 Timeline

• Study Start: 2021-01-22
• Study First Submitted: 2022-04-22
• Study First Submitted QC: 2022-04-27
• Study First Posted: 2022-04-29
• Primary Completion: 2022-06-24
• Study Completion: 2022-06-24
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-20
• Last Update Posted: 2022-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 300

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sec-Meta	methylmalonic acid testing	patients with early breast cancer developed distant metastasis within 5 years
Non-Meta	methylmalonic acid testing	patients with early breast cancer did not develop distant metastasis within 5 years
older	methylmalonic acid testing	patients with breast cancer older than 70 years old with G8 screening
pCR	methylmalonic acid testing	patients with breast cancer reached pCR after neoadjuvant chemotherapy
non-pCR	methylmalonic acid testing	patients with breast cancer did not reach pCR after neoadjuvant chemotherapy
Pri-Meta	methylmalonic acid testing	patients with breast cancer metastasis at first diagnosis

Primary Outcome Measures

Name	Time	Method
MMA levels	baseline	baseline serum MMA levels in pre-defined patients

Trial Locations

Locations (1)

Lab of Experimental Oncology; 🇧🇪 Leuven, State Or Province:, Belgium