NCT04661046

Brief Summary

To explore the correlation between gene mutations of metastatic colorectal cancer and TCM syndrome types based on Second-generation sequencing technology.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2020

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 20, 2020

Completed
10 days until next milestone

Study Start

First participant enrolled

November 30, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 9, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2022

Completed
Last Updated

December 9, 2020

Status Verified

November 1, 2020

Enrollment Period

1.8 years

First QC Date

November 20, 2020

Last Update Submit

December 8, 2020

Conditions

Gene Mutation-Related CancerTraditional Chinese Medicine

Outcome Measures

Primary Outcomes (2)

  • Overall Survival

    OS

    2 years

  • Progression Free Survival

    PFS

    2 years

Study Arms (1)

TCM Syndrome Types

EXPERIMENTAL

Traditional Chinese Medicine

Drug: Traditional Chinese Medicine

Interventions

Traditional Chinese MedicineDRUG

Chinese medicine prescription

Also known as: TCM
TCM Syndrome Types

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A clear pathological diagnosis is a patient with colorectal cancer;
  • Have complete TNM staging information;
  • There is a clear diagnosis of the location and time of metastasis;
  • Age ≥18 years old, ≤80 years old, male or female;
  • There is a clear time for the first treatment with Chinese medicine;
  • Patients who can receive long-term follow-up. -

You may not qualify if:

  • Patients with colorectal cancer diagnosed pathologically as adenosquamous carcinoma, squamous cell carcinoma, carcinoid, small cell carcinoma, malignant lymphoma, etc.;
  • Patients with double cancer, multiple or metastatic colorectal cancer;
  • Combined with severe acute and chronic diseases that may affect treatment and prognosis, such as myocardial infarction, stroke, severe renal insufficiency and mental illness;-

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Medicine, Chinese Traditional

Intervention Hierarchy (Ancestors)

Medicine, East Asian TraditionalMedicine, TraditionalComplementary TherapiesTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2020

First Posted

December 9, 2020

Study Start

November 30, 2020

Primary Completion

August 31, 2022

Study Completion

August 31, 2022

Last Updated

December 9, 2020

Record last verified: 2020-11