Correlation Between PET/CT Parameters and Tumor Markers in Recurrent Breast Cancer
Correlation Between Petct Based Quantitative Parameters and CA 15.3 in Suspected Recurrent Breast Cancer
1 other identifier
observational
72
0 countries
N/A
Brief Summary
Worldwide, breast cancer (BC) is the most frequent type of cancer in women yet, it is associated with relatively lower mortality rates, as it ranks fifth in cancer-related deaths overall, which is attributed to evolution in the treatment of recurrent and metastatic lesions, especially when these lesions were detected early . BC recurrence can occur even 15 years after primary treatment.
Trial Health
Trial Health Score
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participants targeted
Target at P50-P75 for all trials
Started Oct 2021
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 22, 2021
CompletedFirst Posted
Study publicly available on registry
October 1, 2021
CompletedStudy Start
First participant enrolled
October 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2023
CompletedOctober 1, 2021
September 1, 2021
1.5 years
September 22, 2021
September 30, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
identification of recurrence
correlation between PET/CT parameters and the serum level of tumour markers in suspected recurrent BC as well as finding the best cut-off value of tumor markers that can be used in the identification of recurrence
2 years
Study Arms (1)
Recurrent breast cancer patients with elevated tumor markers
PET/CT is the functional imaging tool that can measure increased glucose metabolism in cancer cells by using 18F-FDG. Its ability to identify tumor recurrence before detection of morphologic changes in conventional imaging reflecting its importance in detecting BC recurrence in asymptomatic patients with high tumor markers and negative results of radiological imaging. 18F-FDG PET/CT is frequently used for BC evaluation. However, data on its value in evaluating BC recurrence in patients with elevated tumor markers are limited and unclear
Interventions
Patients with previous breast cancer, already treated and with clinical or biochemical suspicion of disease relapse. All patients will underwent 18F-fluorodeoxyglucose (FDG) PET/CT. In all patients, the value of CA 15.3 was compared to PET/CT. The final diagnosis of relapse will be derived from histopathological sampling As much as possible or radiological follow up for at least 6 months will be compared with PET/CT results.
Eligibility Criteria
female patient with pathologically proved breast cancer who will be referred to do PET\\CT imaging at the nuclear medicine unit, Assiut university hospital due to suspicion of recurrence based on elevated level of tumor marker
You may qualify if:
- female patient with pathologically proved breast cancer who will be referred to do PET\\CT imaging at the nuclear medicine unit, Assiut university hospital due to suspicion of recurrence based on elevated level of tumor marker in the period between October 2021 until the end of the study .
You may not qualify if:
- patients with newly diagnosed BC patients with early stages of BC BC patients with normal serum level of tumor markers
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (4)
Ayala de la Pena F, Ortiz-Munoz B, Quintanar-Verduguez T, Santotoribio JD, de la Cruz S, Trape-Pujol J, Galve-Calvo E, Auge-Fradera JM, Garcia-Gomez J, Gonzalez-Hernandez A. Consensus of the Spanish society of laboratory medicine and the Spanish society of medical oncology on the methodology and criteria for evaluation of circulating tumour markers in breast cancer. Clin Transl Oncol. 2021 Jul;23(7):1272-1280. doi: 10.1007/s12094-020-02529-x. Epub 2021 Feb 7.
PMID: 33550504BACKGROUNDLiu C, Chen M, Shi Y. Downregulation of hsa_circ_0006220 and its correlation with clinicopathological factors in human breast cancer. Gland Surg. 2021 Feb;10(2):816-825. doi: 10.21037/gs-21-42.
PMID: 33708563BACKGROUNDKhushk M, Khan A, Rehman A, Sheraz S, Tunio YM, Rehman K, Rehman D, Ahmed M, Abbas K, Khan ME. The Role of Tumor Markers: Carcinoembryonic Antigen and Cancer Antigen 15-3 in Patients With Breast Cancer. Cureus. 2021 Jul 10;13(7):e16298. doi: 10.7759/cureus.16298. eCollection 2021 Jul.
PMID: 34405063BACKGROUNDStergiou N, Nagel J, Pektor S, Heimes AS, Jakel J, Brenner W, Schmidt M, Miederer M, Kunz H, Roesch F, Schmitt E. Evaluation of a novel monoclonal antibody against tumor-associated MUC1 for diagnosis and prognosis of breast cancer. Int J Med Sci. 2019 Aug 14;16(9):1188-1198. doi: 10.7150/ijms.35452. eCollection 2019.
PMID: 31588183BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Salma Ahmed Samy anwar
Study Record Dates
First Submitted
September 22, 2021
First Posted
October 1, 2021
Study Start
October 1, 2021
Primary Completion
March 30, 2023
Study Completion
May 1, 2023
Last Updated
October 1, 2021
Record last verified: 2021-09