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Status unknownNCT04857203Updated Aug 8, 2022

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

An observational study in Rectal Cancer and Stage III Rectal Cancer, sponsored by Istanbul Training and Research Hospital. Status unknown at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-08-08.

Sponsored by Istanbul Training and Research Hospital · Observational

The sponsor has not verified this record recently (last verified Aug 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Rectal Cancer
  • Stage III Rectal Cancer

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Keywords

  • rectal cancer
  • neoadjuvant
  • vitamin D
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In context

Rectal Neoplasms

1,804 studies on the registry are indexed under Rectal Neoplasms; 520 are open to participants now.

This study's planned enrollment of 60 is below the median of 156 across 421 observational studies indexed under Rectal Neoplasms.

Browse Rectal Neoplasms studies →

Lead sponsor

Istanbul Training and Research Hospital is the lead sponsor of 66 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

All patients with locally advanced rectal cancer

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

    • All patients with locally advanced rectal cancer

Exclusion criteria

Exclusion Criteria:

    • below 18 years old

      • patients who did not received neoadjuvant therapy
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (estimated)
Target follow-up
2 Years
Patient registry
Yes

Groups and cohorts

  • Group 1

    Low levels of Vitamin D

    Diagnostic Test: Vitamin D

  • Group 2

    High levels of Vitamin D

    Diagnostic Test: Vitamin D

Interventions

  • Diagnostic testVitamin D

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

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What researchers measure

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.

    Time frame: 8 weeks

07

Study locations

1 of 1 sites recruiting
  • Istanbul Training and Research Hospital
    Istanbul, None Selected 34098, Turkey (Türkiye)
    • Cihad Tatar, MD · Contact · tatarcihad@gmail.com · +905336599889
    • Mahmut E Cicek, MD · Sub investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 8, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04857203
Lead sponsor
Istanbul Training and Research Hospital
Responsible party
Cihad Tatar (Associate Professor, Istanbul Training and Research Hospital) — Principal investigator
First posted
Apr 23, 2021
Start date
Sep 1, 2020
Primary completion
Dec 31, 2022 (estimated)
Completion
Aug 31, 2023 (estimated)
Last update
Aug 8, 2022

Study contacts

Cihad Tatar, MD
Contact
tatarcihad@gmail.com
+905336599889

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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