NCT02854449

Brief Summary

This study will follow-up different immune cell populations in the blood before, during and after high dose radiation therapy which should give new information of the efficacy of Local Hypofractionated Radiotherapy and a rationale for adjuvant immunotherapy.

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
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2016

Longer than P75 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 1, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 3, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

April 20, 2018

Status Verified

April 1, 2018

Enrollment Period

3.1 years

First QC Date

August 1, 2016

Last Update Submit

April 18, 2018

Conditions

Neoplasms

Keywords

Immune MarkerImmunologic MarkerRadiotherapyDose Hypofractionation

Outcome Measures

Primary Outcomes (1)

  • Percentage of immune cells

    The primary endpoint is the change of the percentage of immune cells before, during and after radiotherapy

    prior to the first fraction of radiotherapy;14(±2) days from the begining of RT; the day (±2) of the last radiotherapy sessions ;one month, 3 months after the last radiotherapy session

Secondary Outcomes (2)

  • Local control

    3 months

  • Acute and Late toxicities

    3 months

Eligibility Criteria

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

Patients receive local hypofractionated radiotherapy

You may qualify if:

  • Patient requiring a hypofractionated irradiation;
  • pathologically confirmed Unspecified Adult Solid Tumor
  • Age ≥ 18 years old
  • KPS≥70
  • Signed written informed consent.

You may not qualify if:

  • Patient treated by chemotherapy, targeted or immunotherapy within 21 days before the first sampling,
  • Pregnant or breastfeeding woman,
  • Patient under guardianship or tutorship.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Gao Xianshu, Master

    Peking University First Hospital

    STUDY CHAIR

Central Study Contacts

Bai Yun, Master

CONTACT

flkmy1@126.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

August 1, 2016

First Posted

August 3, 2016

Study Start

November 1, 2016

Primary Completion

December 1, 2019

Study Completion

December 1, 2020

Last Updated

April 20, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)