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

July 20, 2022 updated by: Qi Wu, KU Leuven

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • State Or Province:
      • Leuven, State Or Province:, Belgium, 3000
        • Lab of Experimental Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

patients with breast cancer admitted into University of Hospital, Leuven, from 2003 to 2015.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MMA levels
Time Frame: baseline
baseline serum MMA levels in pre-defined patients
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

KU Leuven

Investigators

  • Principal Investigator: Hans Wildiers, PhD, UZ Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 22, 2021

Primary Completion (Actual)

June 24, 2022

Study Completion (Actual)

June 24, 2022

Study Registration Dates

First Submitted

April 22, 2022

First Submitted That Met QC Criteria

April 27, 2022

First Posted (Actual)

April 29, 2022

Study Record Updates

Last Update Posted (Actual)

July 22, 2022

Last Update Submitted That Met QC Criteria

July 20, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S64752

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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