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NCT Number: NCT05352737

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Lab of Experimental Oncology

Leuven, State Or Province:, 3000, Belgium

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

methylmalonic acid testing

Diagnostic Test

Primary outcomes

  1. MMA levels

    Time frame: baseline

    baseline serum MMA levels in pre-defined patients

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 29, 2022
Registry last updated
Jul 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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