MicroRNA Signatures

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00005982

Enrollment

150

Registered

2014-04-02

Start date

2014-02-25

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

C18 C20

Interventions

Group 1: Single blood sample for analysis and comparison of the microRNA profiles in patients with diverticulitis, intestinal polyps and early (UICC I-II), lymphogen (UICC III) and hematogen metastasi

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Age >/= 18 years Written informed consent Primary diagnosis of a histological confirmed adenocarcinoma of the colon or rectum Or Acute diverticulitis (verified by CT, Stage I + IIa according to Hansen and Stock) Or Intestinal polyps for endoscopic polypectomy (R0 stage and benign histology) Or Subjects without malignant or inflammatory intestinal diseases (normal subjects)

Exclusion criteria

Exclusion criteria: - History of secondary malignancy within the past 5 years - Acute or subacute ileus - Known chronic-inflammatory bowel disease - Chemotherapy within 2 weeks prior to enrolment - Treatment with steroids or other immune suppressive drugs - Relevant adverse drug reactions of concomitant medications - Non-healing wounds, ulceration or bone fractures - Pregnancy or lactation - For patients with colorectal cancer: ALAT and ASAT > 2.5 ULN, serum bilirubin > 1.5 ULN, serum creatinine > 1.5 ULN - Significant concomitant disease that excludes study participation according to the investigator - Medical or psychiatric disability which prevents proper informed consent - Missing or limited legal capacity

Design outcomes

Primary

Measure	Time frame
Analysis of microRNA profiles in blood samples of patients with diverticulitis, intestinal polyps and different stages of colorectal cancer.	—

Secondary

Measure	Time frame
- Assessment of a predictive microRNA signature for (early) colorectal cancer - Assessment of the sensitivity and specificity of the microRNA signature - Assessment of microRNA signatures for different tumor stages - Assessment of the discriminatory power of the microRNA analysis for the differential diagnosis colorectal cancer versus diverticulitis	—

Countries

Germany

Contacts

Public ContactAxel Stang

Asklepios Klinik Barmbek, Onkologie und Palliativmed.

onkologie.barmbek@asklepios.com+49401818823831

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026