SEMA4C as a Relapse Biomarker in Breast Cancer
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| ClinicalTrials.gov Identifier: NCT03663153 |
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Recruitment Status :
Not yet recruiting
First Posted : September 10, 2018
Last Update Posted : October 8, 2020
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| Condition or disease | Intervention/treatment |
|---|---|
| Breast Cancer | Other: SEMA4C high value follow-up group Other: SEMA4C low value follow-up group |
Breast cancer remains the most common cancer in women worldwide, with approximately 1.68 million new cases, and 0.52 million deaths, annually. Meanwhile the incidence of breast cancer continues to increase. Although regular clinical examination, mammography, ultrasonography, and magnetic resonance imaging can detect some recurrence patients, the lack of robust biomarkers for monitoring of anti-tumor therapies and detection of recurrence reduce the treatment effectiveness of current strategies for breast cancer.
Semaphorin4C (SEMA4C) has been previously identified as a highly expressed protein by breast cancer-associated lymphatic endothelial cells (LECs) using in situ laser capture microdissection of lymphatic vessels, followed by cDNA microarray analysis. Moreover, membrane-bound SEMA4C is cleaved by matrix metalloproteinase (MMPs) to release a soluble form of this protein. The study is undertaken to explore SEMA4C's potential role as an early relapse biomarker in breast cancer.
| Study Type : | Observational |
| Estimated Enrollment : | 4200 participants |
| Observational Model: | Other |
| Time Perspective: | Prospective |
| Official Title: | SEMA4C as a Relapse Biomarker in Breast Cancer |
| Estimated Study Start Date : | September 1, 2021 |
| Estimated Primary Completion Date : | August 1, 2022 |
| Estimated Study Completion Date : | August 1, 2026 |
| Group/Cohort | Intervention/treatment |
|---|---|
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SEMA4C high value follow-up group
Postoperative SEMA4C value is higher than 5.00 ng/ml.
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Other: SEMA4C high value follow-up group
Serum samples will be collected every 3 months for the first year after surgery and then every 6 months to first progression defined as death or recurrence of the breast cancer or until 5 years since last patient in, whichever occurs first. Imaging examination and biopsy or surgery if necessary are recommended for patients with elevated SEMA4C. Serum SEMA4C levels will be tested in single center in order to decrease bias and be measured using a double antibody sandwich ELISA method using in-house SEMA4C detection kits. |
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SEMA4C low value follow-up group
Postoperative SEMA4C value is lower than 5.00 ng/ml.
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Other: SEMA4C low value follow-up group
Serum samples will be collected every 3 months for the first year after surgery and then every 6 months to first progression defined as death or recurrence of the breast cancer or until 5 years since last patient in, whichever occurs first. Imaging examination and biopsy or surgery if necessary are recommended for patients with elevated SEMA4C. Serum SEMA4C levels will be tested in single center in order to decrease bias and be measured using a double antibody sandwich ELISA method using in-house SEMA4C detection kits. |
- diagnostic accuracy (sensitivity, specificity, positive predictive value, negative predictive value) of SEMA4C in predicting recurrence of breast cancer [ Time Frame: 5 years ]Analyze the sensitivity, specificity, positive predictive value, negative predictive value, accuracy of SEMA4C in predicting recurrence of breast cancer
- Disease Free Survival [ Time Frame: 5 years ]Disease Free Survival (DFS) can be determined according to clinical practice based on any of the following: applicable imaging technique, biopsy and surgery.
Biospecimen Retention: Samples Without DNA
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| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Have histologically confirmed new diagnosis of breast cancer according to biopsy or surgery
Exclusion Criteria:
- Patients who are not mentally capable of giving written informed consent
- Serum samples doesn't qualified
- Patients who refuse follow-up on their conditions
- Patients with prior cancer history
- Patients with a diagnosis of other severe acute or chronic medical may increase the risk associated with study participation or may interfere with the interpretation of the study results and, in the judgement of the Investigator, would make the patient inappropriate for enrollment in this study
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03663153
| Contact: Qinglei Gao, MD, PhD | 13871127473 | qingleigao@hotmail.com | |
| Contact: Ding Ma, MD, PhD | 13886090620 | dingma424@126.com |
| Principal Investigator: | Qinglei Gao, MD, PhD | Tongji Hospital |
| Responsible Party: | Qinglei Gao, Clinical Professor, Tongji Hospital |
| ClinicalTrials.gov Identifier: | NCT03663153 |
| Other Study ID Numbers: |
2018-TJ-BCP |
| First Posted: | September 10, 2018 Key Record Dates |
| Last Update Posted: | October 8, 2020 |
| Last Verified: | October 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |