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

Catholic University (KU) of Leuven

Status: Completed

Conditions: Breast Cancer

Treatments: Diagnostic Test: methylmalonic acid testing

Study type: Observational

Funder types: Other

Identifiers

NCT05352737

S64752

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

300 participants in 6 patient groups

Pri-Meta

Description:

patients with breast cancer metastasis at first diagnosis

Treatment:

Diagnostic Test: methylmalonic acid testing

Sec-Meta

Description:

patients with early breast cancer developed distant metastasis within 5 years

Treatment:

Diagnostic Test: methylmalonic acid testing

Non-Meta

Description:

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

Treatment:

Diagnostic Test: methylmalonic acid testing

older

Description:

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

Treatment:

Diagnostic Test: methylmalonic acid testing

pCR

Description:

patients with breast cancer reached pCR after neoadjuvant chemotherapy

Treatment:

Diagnostic Test: methylmalonic acid testing

non-pCR

Description:

patients with breast cancer did not reach pCR after neoadjuvant chemotherapy

Treatment:

Diagnostic Test: methylmalonic acid testing