Clinical trial · Interventional
A 6 microRNA Tool for Stratifying Stage II Colon Cancer of Receiving Adjuvant Chemotherapy
A Multi-site, Open, Perspective Study of Prognostic Value and Benefit From Chemotherapy of Stage II Colon Cancer Based on a 6 microRNA Stratified Tool
- 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)
Whether patients with stage II colon cancer should receive adjuvant chemotherapy or not is still on debate.MicroRNA(miRNA) is a promising tool. Investigators invented a tool consisting of 6 miRNA(miR-21、miR-20a-5p、miR-103a-3p、miR-106b-5p、miR-143-5p and miR-215) that was effective to identify one should accept adjuvant chemotherapy or not. Here investigators randomly assign patients to be assessed by classical pathological features or the miRNA tool of determining who should accept chemotherapy. Disease free survival and overall survival are the end points of observation.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colonic Neoplasms | Colon Neoplasm | ALIAS | 0.90 |
| Effects of Chemotherapy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| A 6 microRNA stratified tool | Other | — | UNRESOLVED |
| A classic stratified tool | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- An experimental group
- description
- A 6 microRNA stratified tool is applied in this group.Investigators defined high risk patient and low risk patient according to the microRNA stratified tool.The high risk group should receive adjuvant chemotherapy while the low risk group observation.
- interventionNames
- Other: A 6 microRNA stratified tool
- type
- OTHER
- label
- A control group
- description
- A classic stratified tool is applied in this group. Investigators defined high risk and low risk patient according to classical pathological features.The high risk group should receive adjuvant chemotherapy while the low risk group observation.
- interventionNames
- Other: A classic stratified tool
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * The informed consent has been obtained from the patient. * With confirmed diagnosis of stage II colon cancer. * With moderate/good ECOG health rating (PS): 0-1 score. * The patient receive no anti-cancer treatment before primary surgery. * The patient receive radical operation for colon cancer with negative margin. Exclusion Criteria: * With severe comorbidities, such as cardiovascular disease, chronic obstructive pulmonary disease, diabetes mellitus, and chronic renal dysfunction. * With bad compliance or contraindication to enrollment. * Pregnant woman or lactating woman. * With contraindication to receive adjuvant chemotherapy.
References
Publications (0)
Data not yet available