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

Breast Cancer Clinical Trial

Official title:

A Retrospective Study Exploring the Role of Serum Methylmalonic Acid (MMA) in Breast Cancer---focusing on Metastasis, Chemotherapy Resistance, and Ageing Effects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05352737
• Other study ID #: S64752
• Status: Completed
• Start date: January 22, 2021
• Est. completion date: June 24, 2022

Study information

• Verified date: July 2022
• Source: KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 frailty.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: June 24, 2022
• Est. primary completion date: June 24, 2022
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Diagnostic Test:
• methylmalonic acid testing

Locations

Country	Name	City	State
Belgium	Lab of Experimental Oncology	Leuven	State Or Province:

Sponsors (1)

Lead Sponsor	Collaborator
KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MMA levels	baseline serum MMA levels in pre-defined patients	baseline