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

Sponsor
Istanbul Training and Research Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04857203
Collaborator
(none)
60
1
35.9
1.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Vitamin D

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
60 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
The Role of Vitamin D in Predicting Response to Neoadjuvant Therapy in Patients With Rectal Cancer
Actual Study Start Date :
Sep 1, 2020
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Aug 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Group 1

Low levels of Vitamin D

Diagnostic Test: Vitamin D
Vitamin D levels will be measured for the patients undergoing neoadjuvant therapy in patients with locally advanced rectal cancer

Group 2

High levels of Vitamin D

Diagnostic Test: Vitamin D
Vitamin D levels will be measured for the patients undergoing neoadjuvant therapy in patients with locally advanced rectal cancer

Outcome Measures

Primary Outcome Measures

  1. The Role of Vitamin D in response to neoadjuvant therapy for the patients with locally advanced rectal cancer [8 weeks]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • • All patients with locally advanced rectal cancer
Exclusion Criteria:
  • • below 18 years old

  • patients who did not received neoadjuvant therapy

Contacts and Locations

Locations

Site City State Country Postal Code
1 Istanbul Training and Research Hospital Istanbul None Selected Turkey 34098

Sponsors and Collaborators

  • Istanbul Training and Research Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Cihad Tatar, Associate Professor, Istanbul Training and Research Hospital
ClinicalTrials.gov Identifier:
NCT04857203
Other Study ID Numbers:
  • 2767
First Posted:
Apr 23, 2021
Last Update Posted:
Aug 8, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Cihad Tatar, Associate Professor, Istanbul Training and Research Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 8, 2022