The Role of Serum Adipokines in Predicting Response to Ne... | NCT04598984

Studies
The Role of Serum Adipokines in Predicting Response to Neoadjuvant Therapy in Patients With Rectal Cancer

NCT04598984

Sponsor

Istanbul Training and Research Hospital

Status

Unknown status

Last Update Posted

Aug 8, 2022Actual

Enrollment

60Estimated

Phase

Not provided

Conditions

Rectal Cancer Stage III

Interventions

serum adipokines

Countries

Turkey (Türkiye)

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

Aug 2022

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 1, 2020Actual

Primary Completion Date

Dec 30, 2022Estimated

Completion Date

Dec 31, 2022Estimated

First Submitted Date

Oct 9, 2020

First Submission Date that Met QC Criteria

Oct 16, 2020

First Posted Date

Oct 22, 2020Actual

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

Aug 5, 2022

Last Update Posted Date

Aug 8, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Cihad Tatar, Associate Profesor, Istanbul Training and Research HospitalPrincipal Investigator

Lead Sponsor

Istanbul Training and Research HospitalOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

It has been shown that adipokines (resistin, leptin, adiponectin) secreted from adipose tissue and proinflammatory cytokines such as IL-6, TNF-a are associated with the risk of developing colorectal cancer. However, the role of these factors in predicting clinical response to neoadjuvant therapy in rectal cancers is unknown. In this study, the role of serum adipokine levels before neoadjuvant therapy in predicting clinical response in patients with rectal cancer is investigated. For this purpose, blood will be drawn from patients with rectal cancer who will receive neoadjuvant therapy, serum adipokines will be studied and clinical response to neoadjuvant therapy will be compared.

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

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Low levels of serum adipokines			Diagnostic Test: serum adipokines
High levels of serum adipokines			Diagnostic Test: serum adipokines

Interventions

Name	Type	Description	Arm Group Labels	Other Names
serum adipokines	Diagnostic Test	Level of serum adipokines will be measured with flow cytometry	High levels of serum adipokines Low levels of serum adipokines

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The Role of Serum Adipokines in Predicting Response to Neoadjuvant Therapy in Patients with Rectal Cancer	The Adiponectin, Adipsin, Leptin, Resistin levels will be measured with flow cytometric analysis.	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients with locally advanced rectal cancer

Exclusion Criteria:

below 18 years old
patients who did not received neoadjuvant therapyAll

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All patients with locally advanced rectal cancer

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Cihad Tatar, MD	Contact	+905336599889		tatarcihad@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Istanbul Training and Research Hospital	Recruiting	Istanbul		34029	Turkey (Türkiye)

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
D012004	Rectal Neoplasms

Ancestor Terms

ID	Term
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided