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

NCT04857203 | Unknown

• 1 other identifier: 2767
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Rectal Cancer; Stage III Rectal Cancer

Keywords

rectal cancer; neoadjuvant; vitamin D

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Group 1

Low levels of Vitamin D

Diagnostic Test: Vitamin D

Group 2

High levels of Vitamin D

Diagnostic Test: Vitamin D

Interventions

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; Group 2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients with locally advanced rectal cancer

You may qualify if:

• All patients with locally advanced rectal cancer

You may not qualify if:

• below 18 years old
• patients who did not received neoadjuvant therapy

Sponsors & Collaborators

• Istanbul Training and Research Hospital: lead

Study Sites (1)

Istanbul Training and Research Hospital

Istanbul, None Selected, 34098, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Vitamin D Response Element

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Response Elements; Enhancer Elements, Genetic; Regulatory Sequences, Nucleic Acid; Base Sequence; Molecular Structure; Biochemical Phenomena; Chemical Phenomena; Promoter Regions, Genetic; Genetic Structures; Genetic Phenomena; Regulatory Elements, Transcriptional; Gene Components; Genes; Genome Components; Genome

Central Study Contacts

Cihad Tatar, MD

CONTACT

+905336599889; tatarcihad@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 21, 2021
• First Posted: April 23, 2021
• Study Start: September 1, 2020
• Primary Completion: December 31, 2022
• Study Completion: August 31, 2023
• Last Updated: August 8, 2022

Record last verified: 2022-08

Locations

TU (1)