Changes of Immunologic Function in Patients of Prostate Cancer Induced After Cryoablation.

NCT ID: NCT02739048

Last Updated: 2016-04-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-30

Study Completion Date

2018-09-30

Brief Summary

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1\. The overall objective of the study: By evaluating the curative effect of CSAP in localized prostate cancer, locally advanced prostate cancer and metastasis advanced prostate cancer, and the change of state in cellular immunity and humoral immunity before and after CSAP. Validate the clinical therapeutic effect of all kinds of prostate cancer, as well as the change of immune status before and after CSAP.

2\. The main content of the study:

1. Included in the samples are patients in hospitals for CSAP. The sample capacity are planned to be 80. The main purpose of the study is to observe the overall survival rate , disease free survival rate, the progress time of the PSA biochemical recurrence as well as the disease progress time.
2. Measure the change of concentration in peripheral blood T lymphocyte subsets (CD3 + T, CD4 + T, CD8 + T, CD4 + / CD8 + T, NK cells) and regulatory T cells before and after cryoablation within 1 month, 3 months and 6 months.
3. Measure the change of concentration in peripheral blood IFN-1, IL-4, IFN-1/IL-4 ratio (Thl/Th2 ratio), and detect the secretion of CD4 + Th tumor-specific IFN-l and the activity of tumor-specific killer CD8 + CTL before and after cryoablation within 2 weeks and 1 month.
4. Before cryoablation, detect the expression and distribution of Follistatin-Like1 (FSTL-1), Besides, verify the connection between the number and activation ratio of tumor local dendritic cells (DC) and the FSTL-1, evaluating the cryoablation effect on the immune response.

Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* patients diagnosed with prostate cancer by pathology
* the age of patients should be from 40 to 80 years old
* do not receive other treatments like radical prostatectomy, radiotherapy, etc

Exclusion Criteria

* can not receive surgery because of bad performance status
* abnormal coagulation function
* receive other treatment before CSAP
* do not want to achieve CSAP because of any reasons
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Jian Kang

Chief Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jian Kang, director

Role: STUDY_DIRECTOR

Shanghai Jiao Tong University School of Medicine

Locations

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Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jian Kang

Role: CONTACT

+86-13901663058

Facility Contacts

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Hui Lin Wang, chief physician

Role: primary

+86-13901635510

Other Identifiers

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XH-16-011

Identifier Type: -

Identifier Source: org_study_id

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