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

Rectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04857203
• Other study ID #: 2767
• Status: Recruiting
• Start date: September 1, 2020
• Est. completion date: August 31, 2023

Study information

• Verified date: August 2022
• Source: Istanbul Training and Research Hospital
• Contact: Cihad Tatar, MD
• Phone: +905336599889
• Email: tatarcihad[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• • All patients with locally advanced rectal cancer

Exclusion Criteria:

• • below 18 years old

• patients who did not received neoadjuvant therapy

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms
• Stage III Rectal Cancer

Intervention

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

Locations

Country	Name	City	State
Turkey	Istanbul Training and Research Hospital	Istanbul	None Selected

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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