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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07151807
Acronym
SIGMA
Enrollment
100
Registered
2025-09-03
Start date
2025-04-01
Completion date
2026-12-31
Last updated
2025-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, IGF1R, Solid Cancers, Solid Tumor Malignancies

Brief summary

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.

Detailed description

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.

Interventions

None listed

Sponsors

Çanakkale Onsekiz Mart University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
IGF-1 and IGF-1Ec levelsFrom enrollment to 6 monthBlood values

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026