Clinical trial · Observational
The Gene Profiles of Primary and Heterogeneous Metastases of Colorectal Cancer
A Study Comparing the Gene Profiles of Primary and Heterogeneous Metastases of Colorectal Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The incidence and mortality of colorectal cancer in China's cancer disease spectrum is on the rise, and it is a common malignant tumor that harms the health of Chinese residents.In patients with synchronous metastatic colorectal cancer, RAS status is highly consistent in primary focus and metastasis, so NCCN guidelines recommend RAS testing of primary or metastatic tissue is feasible .However, there are also some reports that the difference of RAS status between primary and metastatic lesions was up to 22%.In additiont,there are few studies on whether the gene profile of the metastatic lesion is the same as that of the primary lesion in patients with postoperative heterogeneous metastasis in patients with stage III colorectal cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- primary and metastasis lesion
- description
- tissue of colorectal cancer primary lesion and tissue of colorectal cancer metastasis were obtained
Primary outcomes (1)
- measure
- Mutation Consistency of metastatic and primary sites of colorectal cancer patients with postoperative metastasis
- timeFrame
- through study completion, an average of 2 years.
- description
- We do NGS sequencing of both the primary and metastatic tissue sample of the CRC patients. The gene mutation data will be analysis, and the percentage of same and different mutation of the samples will be compared.
Secondary outcomes (1)
- measure
- Mutation Consistency of tissue and blood sample
- timeFrame
- through study completion, an average of 2 years.
- description
- The gene mutation data will be analysis, and the percentage of same and different mutation of the samples will be reported. The consistency between the gene mutation of ctDNA test in blood and the gene mutation of tissue test is analyzed to determine whether the blood ctDNA test could replace the tissue gene test
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥ 18 years old and ≤ 75 years old, both men and women; 2. Patients must have histologically confirmed metastatic colorectal adenocarcinoma and metastases can be punctured by interventional evaluation; 3. ECOG: 0 to 2; 4. Expected survival ≥ 12 weeks; 5. Absolute neutrophil count (ANC) ≥ 1.5 × 109 /L; Hemoglobin ≥ 8g / dL; Platelets ≥100×109/L;(According to the normal value of the clinical trial center) 6. Prothrombin time (PT) \< 1.5 times the upper normal limit and thrombin time (APTT) \< 1.5 times the upper normal limit; 7. Informed consent has been signed. Exclusion Criteria: 1. Patients had surgery within three weeks will be excluded. 2. Patients have known or suspected brain metastases will be excluded. 3. Pregnant or nursing women will be excluded. 4. Patients with severe uncontrolled systemic disease, such as severe active infection, will be excluded. 5. Patients had other malignancies in the past 5 years will be excluded, except cervical carcinoma in situ or basal cell carcinoma of the skin. 6. Patients who were unable to complete the study or sign valid informed consent for medical, social or psychological reasons, which will be determined by researcher, will be excluded. 7. Organ transplant recipients who need immunosuppressive therapy will be excluded. 8. People have been known to be infected with immunodeficiency virus (HIV) or have been known to be serologically positive for HIV will be excluded.
References
Publications (1)
- BACKGROUNDSiyar Ekinci A, Demirci U, Cakmak Oksuzoglu B, Ozturk A, Esbah O, Ozatli T, Celik B, Budakoglu B, Turker I, Bal O, Turan N. KRAS discordance between primary and metastatic tumor in patients with metastatic colorectal carcinoma. J BUON. 2015 Jan-Feb;20(1):128-35. PMID 25778307