Evaluation of Treatment Efficacy by Circulating Tumor Cell Phenotype Surveillance in Breast Cancer Patients

NCT05326295 | Recruiting DMC FDA Device

• 1 other identifier: KYJJ-2021-186
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

The phenotype of circulating tumor cells (CTCs) is supposed to be significant indicator that is correlated the prognosis of breast cancer patients who have completed neoadjuvant chemotherapy, primary tumor surgery with/without adjuvant chemotherapy. The aim of this observational study is to assess the efficacy of CTCs surveillance in predicting the prognosis of breast cancer patients.

Conditions

Breast Neoplasms; Neoplastic Cells, Circulating; Chemotherapy Effect

Outcome Measures

Primary Outcomes (1)

• iDFS

  The survival time from the date of tumor resection to the date of the relapse of the invasive disease.

  From date of enrollment through study completion, up to 10 years.

Secondary Outcomes (2)

• overall survival

  From date of enrollment through study completion, up to 10 years.

• Pathological complete response rate

  From date of enrollment up to 24 weeks

Study Arms (1)

Breast cancer patients

Diagnostic Test: CTC detection

Interventions

CTC detection DIAGNOSTIC_TEST

CTCs separation and enrichment technology. Combined with the prognosis of patients with recurrence and survival time, we explored the evaluation of CTC number, cell phenotype distribution, PDL1 and FOXC2 expression on the prognosis of early stage breast cancer patients. The research results are expected to provide a new effective index and theoretical basis for evaluating the treatment efficacy of breast cancer patients.

Breast cancer patients

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Early stage breast cancer patients

You may qualify if:

• The age is more than 18 years old;
• Pathology confirmed malignant breast tumor;
• No clinical diagnosis of other malignancies, unstable complications or uncontrolled infection;
• Life expectancy is greater than 6 month;
• The main organ function is normal;
• The subjects volunteered to participate in this study, signed informed consent, followed up with good compliance.

You may not qualify if:

• Patients who had suffered from other malignant tumors;
• With uncontrolled bacterial, viral or fungal infections;
• With physical or mental disorders
• Without or limited civil capacity;
• Infected with human immunodeficiency virus (HIV)；
• Circumstances in which the investigator considers it inappropriate to participate in this study.

Sponsors & Collaborators

• Hunan Cancer Hospital: lead

Study Sites (1)

Hunan Cancer Hospital

Changsha, Hunan, 410006, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Neoplastic Cells, Circulating

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Quchang Ouyang

CONTACT

+8673189762161; oyqc1969@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2022
• First Posted: April 13, 2022
• Study Start: March 1, 2019
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2029
• Last Updated: April 13, 2022

Record last verified: 2022-03

Locations

CN (1)