Serum IGF-1 and IGF-1Ec in Malignancy Assessment

This cross-sectional study investigates the relationship between serum IGF-1 and IGF-1Ec (E-peptide/MGF) levels and tumor burden in patients with solid tumors. By analyzing serum samples using ELISA and correlating them with clinical data such as tumor stage, size, metastasis, and lymph node involvement, the study aims to explore whether these biomarkers-particularly IGF-1Ec and the IGF-1Ec/IGF-1 ratio-can reflect tumor progression and serve as potential prognostic indicators.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Cancer IGF1R Neoplasms Solid Cancers Solid Tumor Malignancies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Çanakkale Onsekiz Mart University

Çanakkale, 17020, Turkey (Türkiye)

About this study

Background: Insulin-like Growth Factor-1 (IGF-1) and its splice variant IGF-1Ec (also known as Mechano Growth Factor, MGF) play critical roles in cell proliferation, survival, and tumor progression. Recent evidence suggests that IGF-1Ec may act independently of the classical IGF-1 receptor pathway and contribute to aggressive tumor behavior. However, data on serum IGF-1Ec levels and their correlation with clinical tumor burden remain limited.

Objective: This cross-sectional analytical study aims to quantify serum IGF-1 and IGF-1Ec levels in patients with solid tumors and investigate their association with tumor burden parameters such as clinical stage, tumor size, lymph node involvement, and metastasis. The IGF-1Ec/IGF-1 ratio will also be evaluated as a potential prognostic biomarker.

Methods: Serum samples will be collected from approximately 60 patients diagnosed with solid tumors. IGF-1 and IGF-1Ec levels will be measured using validated ELISA kits. Clinical tumor burden will be assessed from medical records (TNM staging, metastasis, tumor diameter). Statistical analysis will include group comparisons and correlation tests.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age ≥ 18 years
Histologically confirmed diagnosis of a solid tumor
Clinically stable condition, prior to chemotherapy or during standard follow-up
Ability to provide informed consent

Exclusion criteria

Hematological malignancies (e.g., leukemia, lymphoma)
Acute or chronic liver or kidney failure
Current use (within 1 month) of corticosteroids, growth hormone, or medications affecting IGF-1 levels
Pregnancy or lactation
Coagulopathy or severe anemia preventing safe venipuncture

Treatment and study plan

Primary outcomes

IGF-1 and IGF-1Ec levels

Time frame: From enrollment to 6 month

Blood values

Sponsors and collaborators

Lead sponsor

Çanakkale Onsekiz Mart University

Other

Registry information

Official study title

Evaluation of Serum IGF-1 and IGF-1Ec (E-peptide/MGF) Levels and Their Association With Tumor Burden in Patients With Solid Tumors

Acronym: SIGMA

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2026
First posted: Sep 3, 2025
Registry last updated: Sep 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Recruiting