Immune Checkpoints in Predicting Response to Neoadjuvant Therapy in Rectal Cancer

NCT05457075 | Completed

• 1 other identifier: Neoadjuvant rectum
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

Colorectal cancer is the third most frequently diagnosed type of cancer in the world. Recent developments in the treatment of cancers suggest that immune checkpoint inhibitors will play an important role. Many studies have documented many types of soluble receptors and ligands that can be detected in plasma in cancer, and plasma levels of these molecules correlate with cancer severity. There is only one study in the literature evaluating the status of soluble immune control points in patients with rectal cancer. The aim of this study is to investigate the role of serum immune checkpoints before neoadjuvant therapy in predicting clinical response in patients with rectal cancer. In this way, it is aimed to show whether immune checkpoints are predictive markers that can predict response to neoadjuvant therapy in patients with stage II-III rectal cancer.

Conditions

Rectal Cancer

Keywords

Neoadjuvant Therapy; Rectal Cancer; Immune Checkpoints

Outcome Measures

Primary Outcomes (1)

• Soluble immune checkpoints

  sCD25 (IL-2Ra), 4-1BB, B7.2 (CD86), Free Active TGF-β1, CTLA-4, PD-L1, PD-1, Tim-3, LAG-3, Galectin-9

  Before neoadjuvant treatment

Study Arms (1)

Case

Stage II-III rectal cancer patients who have neoadjuvant therapy

Diagnostic Test: Immune checkpoint measure

Interventions

Immune checkpoint measure DIAGNOSTIC_TEST

The measurement of soluble immune checkpoints of stage II-III rectal cancer before neoadjuvant treatment

Case

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who were diagnosed with stage II-III rectal cancer in the General Surgery outpatient clinic of Istanbul Training and Research Hospital between May 2022 and October 2022 and required neoadjuvant treatment

You may qualify if:

• Over 18 years old,
• Patients who will receive neoadjuvant therapy with clinically and histopathologically proven stage II-III rectal cancer

You may not qualify if:

• Known immunodeficiency
• Having a primary malignancy other than rectal cancer,
• Pregnants,
• Patients younger than 18 years and older than 90 years,
• Patients who refused to participate in the study

Sponsors & Collaborators

• Istanbul Training and Research Hospital: lead

Study Sites (1)

Istanbul Training and Research Hospital

Istanbul, 34098, Turkey (Türkiye)

Location

Related Publications (3)

• Tominaga T, Akiyoshi T, Yamamoto N, Taguchi S, Mori S, Nagasaki T, Fukunaga Y, Ueno M. Clinical significance of soluble programmed cell death-1 and soluble programmed cell death-ligand 1 in patients with locally advanced rectal cancer treated with neoadjuvant chemoradiotherapy. PLoS One. 2019 Feb 26;14(2):e0212978. doi: 10.1371/journal.pone.0212978. eCollection 2019.

  PMID: 30807610 BACKGROUND

• Sasidharan Nair V, Toor SM, Taha RZ, Shaath H, Elkord E. DNA methylation and repressive histones in the promoters of PD-1, CTLA-4, TIM-3, LAG-3, TIGIT, PD-L1, and galectin-9 genes in human colorectal cancer. Clin Epigenetics. 2018 Aug 6;10(1):104. doi: 10.1186/s13148-018-0539-3.

  PMID: 30081950 RESULT

• Omura Y, Toiyama Y, Okugawa Y, Yin C, Shigemori T, Kusunoki K, Kusunoki Y, Ide S, Shimura T, Fujikawa H, Yasuda H, Hiro J, Ohi M, Kusunoki M. Prognostic impacts of tumoral expression and serum levels of PD-L1 and CTLA-4 in colorectal cancer patients. Cancer Immunol Immunother. 2020 Dec;69(12):2533-2546. doi: 10.1007/s00262-020-02645-1. Epub 2020 Jun 23.

  PMID: 32577816 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma of the rectal cancer patients

MeSH Terms

Conditions

Rectal Neoplasms

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

Study Officials

• Ufuk Oguz Idiz, Assoc.Prof.

  Istanbul Training and Reseach Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. MD. PhD

Study Record Dates

• First Submitted: July 9, 2022
• First Posted: July 13, 2022
• Study Start: May 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: February 15, 2023
• Last Updated: May 9, 2023

Record last verified: 2023-05

Locations

TU (1)