Breast NeoplasmCTCSFBCNCT05633680
Circulating Tumor Cells Screen for Breast Cancer
An observational study of Breast Neoplasm and Neoplastic Cells, Circulating, run by Handan First Hospital at 1 site in China.
Trial summary
A prospective study was used to collect patients considering breast cancer admitted to our general surgery department from 2019-6 to 2023-8, to identify the case group (breast cancer) and the control group (non-breast cancer), to compare the differences in CTC in peripheral blood between the two groups, and to draw… Read more about this study
- Who is it for?
- Ages 18 to 85 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Neoplasm, Neoplastic Cells, Circulating
- What is being tested?
- Peripheral blood sampling for circulating tumor cells
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 20 Feb 2020to 20 Jun 2023
- How long will I take part?
- 3 Years
- 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 18 to 85 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients with a clinical diagnosis of breast cancer, patients with benign breast disease (BBD), and healthy females were recruited for this study, Patients with benign breast disease and healthy women as negative controls.
Who may be able to join
- Clinical diagnosis of breast cancer Must be able to cooperate with the examination
Who cannot join
- patients were currently undergoing or had prior cancer treatment; patients had other conditions which investigators thought not suitable for the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Detection of Folate Receptor-positive Circulating Tumor Cells as a Biomarker for Diagnosis
A prospective study was used to collect patients considering breast cancer admitted to our general surgery department from 2019-6 to 2023-8, to identify the case group (breast cancer) and the control group (non-breast cancer), to compare the differences in CTC in peripheral blood between the two groups, and to draw conclusions after statistical analysis.
Read the detailed description
This project is a prospective study by collecting clinical data from breast cancer and non-breast cancer patients admitted to our general surgery department from 2020 to 2023, and drawing peripheral blood for CTC testing. The clinical data of 200 patients were initially collected and grouped, with the study group positioned as breast cancer patients (patients with pathologically determined breast cancer) and the control group as non-breast cancer patients (patients with benign breast tumors and healthy women), to investigate the expression of CTC in breast cancer and correlation with the degree of metastasis, as well as to further understand the relationship between CTC in peripheral blood and breast cancer clinicopathology. The circulating tumor cell enrichment was compared between the two groups, and the data were derived for statistical analysis to draw conclusions, as well as to identify shortcomings and make improvements to the existing problems.
- Conditions
- Breast Neoplasm, Neoplastic Cells, Circulating
- Being tested
- Peripheral blood sampling for circulating tumor cells
- Keywords
- Breast cancer, Circulating tumor cells
- Medical subject headings
- Breast Neoplasms, Neoplastic Cells, Circulating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripheral blood sampling for circulating tumor cellsDiagnostic test
Patients had 3-4 ml of venous blood drawn on day 1 after admission, ethylene diamine tetra acetic acid (EDTA) was used for anticoagulation, samples were stored at 4 ℃, and CTCs analysis was performed within 24 hours after collection. .FU/3 ml was used as the unit for CTC quantification.
| Study group | Role | What they receive |
|---|---|---|
| Breast cancer group | Breast cancer is finally determined through breast puncture biopsy or excisional tissue biopsy and sent for pathological diagnosis Receives: Diagnostic Test: Peripheral blood sampling for circulating tumor cells | |
| Non-breast cancer group | By breast puncture biopsy or excisional tissue biopsy and sent to pathology for final determination of benign tumor. and healthy women Receives: Diagnostic Test: Peripheral blood sampling for circulating tumor cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrichment of circulating tumor cells
The main test was the enrichment of circulating tumor cells in the peripheral blood of the two groups of patients.FU/3 ml was used as the unit for CTC quantification.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2022
- Study start20 Feb 2020
- Primary completion20 Apr 2023 (estimated)
- Study completion20 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Handan First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, kunwu-yan, Handan First Hospital
- Investigators
- kunwu yan, Master, Principal investigator, Handan First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05633680
- Sponsor's protocol ID
- handan1
- Other IDs
- 20200187
- Acronym
- CTCSFBC
- Status last verified
- Mar 2023
- First submitted
- 21 Nov 2022
- Last updated
- 13 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Early Breast Cancer Trialists' Collaborative Group (EBCTCG); Darby S, McGale P, Correa C, Taylor C, Arriagada R, Clarke M, Cutter D, Davies C, Ewertz M, Godwin J, Gray R, Pierce L, Whelan T, Wang Y, Peto R. Effect of radiotherapy after breast-conserving surgery on 10-year recurrence and 15-year breast cancer death: meta-analysis of individual patient data for 10,801 women in 17 randomised trials. Lancet. 2011 Nov 12;378(9804):1707-16. doi: 10.1016/S0140-6736(11)61629-2. Epub 2011 Oct 19.
PubMed 22019144Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
PubMed 33538338Chen C, Ke J, Zhou XE, Yi W, Brunzelle JS, Li J, Yong EL, Xu HE, Melcher K. Structural basis for molecular recognition of folic acid by folate receptors. Nature. 2013 Aug 22;500(7463):486-9. doi: 10.1038/nature12327. Epub 2013 Jul 14.
PubMed 23851396Haber DA, Velculescu VE. Blood-based analyses of cancer: circulating tumor cells and circulating tumor DNA. Cancer Discov. 2014 Jun;4(6):650-61. doi: 10.1158/2159-8290.CD-13-1014. Epub 2014 May 6.
PubMed 24801577Sparano J, O'Neill A, Alpaugh K, Wolff AC, Northfelt DW, Dang CT, Sledge GW, Miller KD. Association of Circulating Tumor Cells With Late Recurrence of Estrogen Receptor-Positive Breast Cancer: A Secondary Analysis of a Randomized Clinical Trial. JAMA Oncol. 2018 Dec 1;4(12):1700-1706. doi: 10.1001/jamaoncol.2018.2574.
PubMed 30054636Goodman CR, Seagle BL, Friedl TWP, Rack B, Lato K, Fink V, Cristofanilli M, Donnelly ED, Janni W, Shahabi S, Strauss JB. Association of Circulating Tumor Cell Status With Benefit of Radiotherapy and Survival in Early-Stage Breast Cancer. JAMA Oncol. 2018 Aug 1;4(8):e180163. doi: 10.1001/jamaoncol.2018.0163. Epub 2018 Aug 9.
PubMed 29800954Banko P, Lee SY, Nagygyorgy V, Zrinyi M, Chae CH, Cho DH, Telekes A. Technologies for circulating tumor cell separation from whole blood. J Hematol Oncol. 2019 May 14;12(1):48. doi: 10.1186/s13045-019-0735-4.
PubMed 31088479
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Folate Receptor-positive Circulating Tumor Cells as a Biomarker for Diagnosis
- ClinicalTrials.gov ID
- NCT05633680
- Acronym / sponsor ID
- CTCSFBC / handan1
- Conditions
- Breast Neoplasm, Neoplastic Cells, Circulating
- Keywords
- Breast cancer, Circulating tumor cells
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Handan First HospitalUniversity, hospital or other
- Study start
- 20 Feb 2020 (actual)
- Primary completion
- 20 Apr 2023 (estimated)
- Study completion
- 20 Jun 2023 (estimated)
- First posted
- 1 Dec 2022 (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.
A prospective study was used to collect patients considering breast cancer admitted to our general surgery department from 2019-6 to 2023-8, to identify the case group (breast cancer) and the control group (non-breast cancer), to compare the differences in CTC in peripheral blood between the two groups, and to draw conclusions after statistical analysis.
Detailed description
This project is a prospective study by collecting clinical data from breast cancer and non-breast cancer patients admitted to our general surgery department from 2020 to 2023, and drawing peripheral blood for CTC testing. The clinical data of 200 patients were initially collected and grouped, with the study group positioned as breast cancer patients (patients with pathologically determined breast cancer) and the control group as non-breast cancer patients (patients with benign breast tumors and healthy women), to investigate the expression of CTC in breast cancer and correlation with the degree of metastasis, as well as to further understand the relationship between CTC in peripheral blood and breast cancer clinicopathology. The circulating tumor cell enrichment was compared between the two groups, and the data were derived for statistical analysis to draw conclusions, as well as to identify shortcomings and make improvements to the existing problems.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breast cancer group | – | Diagnostic Test: Peripheral blood sampling for circulating tumor cellsBreast cancer is finally determined through breast puncture biopsy or excisional tissue biopsy and sent for pathological diagnosis |
| Non-breast cancer group | – | Diagnostic Test: Peripheral blood sampling for circulating tumor cellsBy breast puncture biopsy or excisional tissue biopsy and sent to pathology for final determination of benign tumor. and healthy women |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients with a clinical diagnosis of breast cancer, patients with benign breast disease (BBD), and healthy females were recruited for this study, Patients with benign breast disease and healthy women as negative controls.
Key inclusion criteria (1 listed)
- Clinical diagnosis of breast cancer Must be able to cooperate with the examination
Key exclusion criteria (1 listed)
- patients were currently undergoing or had prior cancer treatment; patients had other conditions which investigators thought not suitable for the study.
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 |
|---|---|---|
| Peripheral blood sampling for circulating tumor cellsPatients had 3-4 ml of venous blood drawn on day 1 after admission, ethylene diamine tetra acetic acid (EDTA) was used for anticoagulation, samples were stored at 4 ℃, and CTCs analysis was performed within 24 hours after collection. .FU/3 ml was used as the unit for CTC quantification. | Diagnostic test | Breast cancer group, Non-breast cancer group |
Primary outcome
Enrichment of circulating tumor cells
Time frame: 1 week
The main test was the enrichment of circulating tumor cells in the peripheral blood of the two groups of patients.FU/3 ml was used as the unit for CTC quantification.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2023.
- Background: PubMed 22019144Early Breast Cancer Trialists' Collaborative Group (EBCTCG); Darby S, McGale P, Correa C, Taylor C, Arriagada R, Clarke M, Cutter D, Davies C, Ewertz M, Godwin J, Gray R, Pierce L, Whelan T, Wang Y, Peto R. Effect of radiotherapy after breast-conserving surgery on 10-year recurrence and 15-year breast cancer death: meta-analysis of individual patient data for 10,801 women in 17 randomised trials. Lancet. 2011 Nov 12;378(9804):1707-16. doi: 10.1016/S0140-6736(11)61629-2. Epub 2011 Oct 19.
- Background: PubMed 33538338Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
- Background: PubMed 23851396Chen C, Ke J, Zhou XE, Yi W, Brunzelle JS, Li J, Yong EL, Xu HE, Melcher K. Structural basis for molecular recognition of folic acid by folate receptors. Nature. 2013 Aug 22;500(7463):486-9. doi: 10.1038/nature12327. Epub 2013 Jul 14.
- Background: PubMed 24801577Haber DA, Velculescu VE. Blood-based analyses of cancer: circulating tumor cells and circulating tumor DNA. Cancer Discov. 2014 Jun;4(6):650-61. doi: 10.1158/2159-8290.CD-13-1014. Epub 2014 May 6.
- Background: PubMed 30054636Sparano J, O'Neill A, Alpaugh K, Wolff AC, Northfelt DW, Dang CT, Sledge GW, Miller KD. Association of Circulating Tumor Cells With Late Recurrence of Estrogen Receptor-Positive Breast Cancer: A Secondary Analysis of a Randomized Clinical Trial. JAMA Oncol. 2018 Dec 1;4(12):1700-1706. doi: 10.1001/jamaoncol.2018.2574.
- Background: PubMed 29800954Goodman CR, Seagle BL, Friedl TWP, Rack B, Lato K, Fink V, Cristofanilli M, Donnelly ED, Janni W, Shahabi S, Strauss JB. Association of Circulating Tumor Cell Status With Benefit of Radiotherapy and Survival in Early-Stage Breast Cancer. JAMA Oncol. 2018 Aug 1;4(8):e180163. doi: 10.1001/jamaoncol.2018.0163. Epub 2018 Aug 9.
- Background: PubMed 31088479Banko P, Lee SY, Nagygyorgy V, Zrinyi M, Chae CH, Cho DH, Telekes A. Technologies for circulating tumor cell separation from whole blood. J Hematol Oncol. 2019 May 14;12(1):48. doi: 10.1186/s13045-019-0735-4.
- Individual participant dataSharing planned: Undecided
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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.
kunwu yan, Master principal investigator
Handan First Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Neoplasm and Neoplastic Cells, Circulating, run by Handan First Hospital at 1 site in China.
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 13 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrichment of circulating tumor cells (time frame: 1 week). 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 NCT05633680, which also lists 7 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 13 Mar 2023.