Predicting Response to Chemotherapy in Colorectal Cancer... | NCT06495827

Studies
Predicting Response to Chemotherapy in Colorectal Cancer Via Multi-dimensional Analyses of the Tumor Associated Neutrophils

NCT06495827

Sponsor

Fudan University

Status

Completed

Last Update Posted

Jul 11, 2024Actual

Enrollment

653Actual

Phase

Not provided

Conditions

Tumor Associated Neutrophils

Interventions

No different intenvention

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2010Actual

Primary Completion Date

Jul 2020Actual

Completion Date

Aug 2023Actual

First Submitted Date

Jul 3, 2024

First Submission Date that Met QC Criteria

Jul 10, 2024

First Posted Date

Jul 11, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 10, 2024

Last Update Posted Date

Jul 11, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

A single biomarker is not adequate to identify patients with colorectal cancer (CRC) who have the potential to benefit from adjuvant therapy, presumably owing to the complexity of tumor-infiltrating immune cells (TIICs). The density and spatial organization of TIICs has not been definitely established to explore their predictive value. This study aimed to investigate the prognostic significance of TIICs and its biological predictive value in CRC.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

653Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
response cohort		CRC patients with response status after chemotherapy	Other: No different intenvention
resistance cohort		CRC patients with resistance status after chemotherapy	Other: No different intenvention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No different intenvention	Other	No different intenvention	resistance cohort response cohort

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
PFS	From date of operation until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months	From date of operation until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Voluntarily sign a written ICF.
The Eastern Cancer Collaborative Organization (ECOG) has a physical fitness score of 0 or 1.
The expected survival period is ≥ 3 months.

5. Subjects diagnosed with metastatic colorectal adenocarcinoma by histology or cytology.

6. Colorectal cancer patients who have not received systematic anti-tumor therapy in the past.

Exclusion Criteria:

Subjects suffered from other malignant tumors within 3 years before enrollment, except for cured local tumors (such as basal cell skin cancer, squamous cell skin cancer, superficial bladder cancer, cervical carcinoma in situ, etc.).
Simultaneously enroll in another clinical study, unless it is an observational, non-interference clinical study or a follow-up period of an intervention study.
Received systematic anti-tumor therapy (chemotherapy) within 3 weeks prior to the first administration

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

The study enrolled multiple cohorts, consisting of 653 tumor microarray specimens of CRC patients from Zhongshan Hospital

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided