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

NCT ID: NCT04857203

Last Updated: 2022-08-08

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2023-08-31

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Group 1

Low levels of Vitamin D

Vitamin D

Intervention Type: DIAGNOSTIC_TEST

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

Vitamin D

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Vitamin D

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• • All patients with locally advanced rectal cancer

Exclusion Criteria

• • below 18 years old

• patients who did not received neoadjuvant therapy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istanbul Training and Research Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Cihad Tatar

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Istanbul Training and Research Hospital

Istanbul, None Selected, Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Cihad Tatar, MD

Role: CONTACT

tatarcihad@gmail.com

+905336599889

Facility Contacts

Cihad Tatar, MD

Role: primary

tatarcihad@gmail.com

+905336599889

Other Identifiers

2767

Identifier Type: -

Identifier Source: org_study_id