The Role of Vitamin D in Predicting Response to Neoadjuva... | NCT04857203

Studies
The Role of Vitamin D in Predicting Response to Neoadjuvant Therapy in Patients With Rectal Cancer

NCT04857203

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 Rectal Cancer

Interventions

Vitamin D

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 31, 2022Estimated

Completion Date

Aug 31, 2023Estimated

First Submitted Date

Apr 21, 2021

First Submission Date that Met QC Criteria

Apr 21, 2021

First Posted Date

Apr 23, 2021Actual

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 Professor, 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 reported that better local control is achieved and sphincters are preserved at a higher rate with curative resections performed after neoadjuvant chemoradiotherapy in patients with locally advanced rectal cancers. In addition, it has been reported that local recurrence is reduced and survival is prolonged in patients with complete pathological response to neoadjuvant therapy. Therefore, the importance of predicting patients with pathological complete response has increased.

It has been reported that data obtained from PET-CT scans and clinical information such as tumor size, T stage, and N stage may be useful in predicting the response to neoadjuvant therapy in patients with locally advanced rectal cancer.

Consideration of blood biomarkers in predicting neoadjuvant response can be a very attractive option. Because samples are easily collected, relatively inexpensive to measure, and contain information about different aspects of tumor biology. There are a limited number of blood biomarkers such as CEA and IL-6 that have been studied in the literature.

Experimental studies show that vitamin D suppresses inflammation and protects against cancer by triggering differentiation. In 1980, Cedric and Frank Garland stated for the first time that vitamin D may affect the survival of the patient after the diagnosis of colorectal cancer. In later studies, a positive relationship was reported between the serum level of 25-hydroxyvitamin D - 25 (OH) D and survival rates for colorectal cancer, breast and prostate cancer. In addition, 25 (OH) D serum concentration has been shown to be inversely related to colorectal cancer progression.

In the light of all these information, the role of serum vitamin D levels before neoadjuvant treatment in predicting pathological response in patients with rectal cancer is investigated in this study.

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

Yes

Target Follow-Up Duration

2 Years

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
Group 1		Low levels of Vitamin D	Diagnostic Test: Vitamin D
Group 2		High levels of Vitamin D	Diagnostic Test: Vitamin D

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vitamin D	Diagnostic Test	Vitamin D levels will be measured for the patients undergoing neoadjuvant therapy in patients with locally advanced rectal cancer	Group 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The Role of Vitamin D in response to neoadjuvant therapy for the patients with locally advanced rectal cancer	The Role of Vitamin D in Predicting Response to Neoadjuvant Therapy in Patients with Rectal Cancer Vitamin D levels will be measured for all the patients just before the neoadjuvant therapy.	8 weeks

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 therapy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

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	None Selected	34098	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

Intervention Browse Module

MeSH Terms

ID	Term
D030181	Vitamin D Response Element

Ancestor Terms

ID	Term
D020218	Response Elements
D004742	Enhancer Elements, Genetic
D012045	Regulatory Sequences, Nucleic Acid
D001483	Base Sequence

Browse Leaves

Not provided

Browse Branches

Not provided