NCT04215861

Brief Summary

Blood, saliva and urine samples of tumor patients on the day of admission and discharge were collected for Raman spectral analysis, which provided exploration for the prediction of efficacy, follow-up and prognosis according to the variation characteristics of Raman spectral.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 11, 2019

Completed
22 days until next milestone

First Posted

Study publicly available on registry

January 2, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

January 2, 2020

Status Verified

December 1, 2019

Enrollment Period

2 years

First QC Date

December 11, 2019

Last Update Submit

December 31, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • Raman spectra

    Blood, saliva and urine samples of tumor patients on the day of admission and discharge were collected to analyze the signal changes of Raman spectrum

    the 1st day before operation

  • Raman spectra

    Blood, saliva and urine samples of tumor patients on the day of admission and discharge were collected to analyze the signal changes of Raman spectrum

    the 1st day after operation

Secondary Outcomes (3)

  • progression-free survival

    through study completion, an average of 1 year

  • overall survival

    through study completion, an average of 1 year

  • objective response rate

    through study completion, an average of 1 year

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

* 18-80 years old; * The patient whose tumor (tissue or cell) was first diagnosed by pathology; * Plan to receive routine clinical treatment: chemotherapy, radiotherapy, surgery, intervention, targeted therapy, traditional Chinese medicine treatment and biological immunotherapy; * Have relevant indications for treatment and have no contraindications;

You may qualify if:

  • years old;
  • The patient whose tumor (tissue or cell) was first diagnosed by pathology;
  • Plan to receive routine clinical treatment: chemotherapy, radiotherapy, surgery, intervention, targeted therapy, traditional Chinese medicine treatment and biological immunotherapy;
  • Have relevant indications for treatment and have no contraindications;

You may not qualify if:

  • Severe or uncontrollable systemic diseases (such as unstable or uncompensated respiratory, heart, liver or kidney diseases, etc.);
  • Other circumstances considered inappropriate by the researcher to participate in the study;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, 116000, China

RECRUITING

MeSH Terms

Conditions

Lung NeoplasmsLiver NeoplasmsStomach NeoplasmsBreast Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesDigestive System NeoplasmsDigestive System DiseasesLiver DiseasesGastrointestinal NeoplasmsGastrointestinal DiseasesStomach DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Xiaonan Cui, MD,PhD

    The First Affiliated Hospital of Dalian Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaonan Cui, MD,PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2019

First Posted

January 2, 2020

Study Start

October 1, 2019

Primary Completion

October 1, 2021

Study Completion

October 1, 2021

Last Updated

January 2, 2020

Record last verified: 2019-12

Locations