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

NCT05352737 | Completed DMC

• 1 other identifier: S64752
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• MMA levels

  baseline serum MMA levels in pre-defined patients

  baseline

Study Arms (6)

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

Interventions

methylmalonic acid testing DIAGNOSTIC_TEST

Non-Meta; Pri-Meta; Sec-Meta; non-pCR; older; pCR

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• KU Leuven: lead

Study Sites (1)

Lab of Experimental Oncology

Leuven, State Or Province:, 3000, Belgium

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

peripheral serum

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Hans Wildiers, PhD

  UZ Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: April 22, 2022
• First Posted: April 29, 2022
• Study Start: January 22, 2021
• Primary Completion: June 24, 2022
• Study Completion: June 24, 2022
• Last Updated: July 22, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)