Changes of Immunologic Function in Patients of Prostate C... | NCT02739048

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

NCT02739048

Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Status

Unknown status

Last Update Posted

Apr 21, 2016Estimated

Enrollment

80Estimated

Phase

Not provided

Conditions

Prostate Cancer

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2015

Primary Completion Date

Sep 2018Estimated

Completion Date

Sep 2018Estimated

First Submitted Date

Apr 12, 2016

First Submission Date that Met QC Criteria

Apr 12, 2016

First Posted Date

Apr 14, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 20, 2016

Last Update Posted Date

Apr 21, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jian Kang, Chief Physician, Xinhua Hospital, Shanghai Jiao Tong University School of MedicinePrincipal Investigator

Lead Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of MedicineOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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:

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.
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.
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.
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

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
humoral immunity and cellular immunity will be activated after CSAP for patients of prostate cancer	All 80 participants' peripheral blood will be collected before CSAP and after CSAP to detect the concentration of T lymphocyte subsets (CD3 + T, CD4 + T, CD8 + T, CD4 + / CD8 + T, NK cells), IFN-1, IL-4, IFN-1/IL-4 ratio (Thl/Th2 ratio) and FSTL-1, and to comment the change of activity of humoral immunity and cellular immunity.	3 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

80 patients diagnose with prostate

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jian Kang	Contact	+86-13901663058		kjjjjd@yahoo.com

Overall Officials

Name	Affiliation	Role
Jian Kang, director	Shanghai Jiao Tong University School of Medicine	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shanghai Changzheng Hospital	Recruiting	Shanghai	Shanghai Municipality	200092	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms

Ancestor Terms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided