Breast CancerNCT05064475
Correlation Between PET/CT Parameters and Tumor Markers in Recurrent Breast Cancer
An observational study of Breast Cancer, run by Assiut University.
Trial 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… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- PET/CT
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2021to 1 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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
Who may be able to join
- 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 .
Who cannot join
- patients with newly diagnosed BC patients with early stages of BC BC patients with normal serum level of tumor markers
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Correlation Between Petct Based Quantitative Parameters and CA 15.3 in Suspected Recurrent Breast Cancer
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.
Read the detailed description
life-long routine monitoring is mandatory. Although histopathologic confirmation is the definitive diagnostic method for BC recurrence, it is not always easy to perform as in cases with deeply located or very small-size lesions, or lesion too close to organs or great vessels, making sampling either inaccessible or hazardous. BC recurrence can be assessed using morphological imaging studies or tumor markers. Mammography, ultrasound (US), computed tomography (CT), and magnetic resonance imaging (MRI) are currently the most commonly used morphological imaging methods for detecting breast cancer recurrence. However, both of the two modalities have some restrictions.
Cancer antigen 15-3 (CA 15-3) and carcinoembryonic antigen (CEA) are two tumor markers that are frequently used in the monitoring of BC patients . However, the findings of many studies on these markers in BC follow-up are conflicting.
The introduction of integrated 2-deoxy-2-[18 F] fluoro-D-glucose (18FDG) positron emission tomography (PET) computed tomography (CT), known as PET/CT, has become a helpful tool for this purpose.
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
- Conditions
- Breast Cancer
- Being tested
- PET/CT
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/CTDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2021
- Study start1 Oct 2021 (estimated)
- Primary completion30 Mar 2023 (estimated)
- Study completion1 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SASamy, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05064475
- Sponsor's protocol ID
- Cpetptmrbc
- Status last verified
- Sep 2021
- First submitted
- 22 Sep 2021
- Last updated
- 1 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33550504Liu 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.
PubMed 33708563Khushk 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.
PubMed 34405063Stergiou 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.
PubMed 31588183
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Petct Based Quantitative Parameters and CA 15.3 in Suspected Recurrent Breast Cancer
- ClinicalTrials.gov ID
- NCT05064475
- Acronym / sponsor ID
- Cpetptmrbc
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (estimated)
- Primary completion
- 30 Mar 2023 (estimated)
- Study completion
- 1 May 2023 (estimated)
- First posted
- 1 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
life-long routine monitoring is mandatory. Although histopathologic confirmation is the definitive diagnostic method for BC recurrence, it is not always easy to perform as in cases with deeply located or very small-size lesions, or lesion too close to organs or great vessels, making sampling either inaccessible or hazardous. BC recurrence can be assessed using morphological imaging studies or tumor markers. Mammography, ultrasound (US), computed tomography (CT), and magnetic resonance imaging (MRI) are currently the most commonly used morphological imaging methods for detecting breast cancer recurrence. However, both of the two modalities have some restrictions.
Cancer antigen 15-3 (CA 15-3) and carcinoembryonic antigen (CEA) are two tumor markers that are frequently used in the monitoring of BC patients . However, the findings of many studies on these markers in BC follow-up are conflicting.
The introduction of integrated 2-deoxy-2-[18 F] fluoro-D-glucose (18FDG) positron emission tomography (PET) computed tomography (CT), known as PET/CT, has become a helpful tool for this purpose.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Recurrent breast cancer patients with elevated tumor markers | – | Diagnostic Test: PET/CTPET/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 |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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
Key inclusion criteria (1 listed)
- 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 .
Key exclusion criteria (1 listed)
- patients with newly diagnosed BC patients with early stages of BC BC patients with normal serum level of tumor markers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET/CTPatients 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. | Diagnostic test | Recurrent breast cancer patients with elevated tumor markers |
Primary outcome
identification of recurrence
Time frame: 2 years
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2021.
- Background: PubMed 33550504Ayala 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.
- Background: PubMed 33708563Liu 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.
- Background: PubMed 34405063Khushk 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.
- Background: PubMed 31588183Stergiou 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Salma Ahmed Samy (01069720261, rehabsamyyy1995@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
identification of recurrence (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05064475, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2021.