Tumor Response in Hypofractionated Radiotherapy

NCT ID: NCT02854449

Last Updated: 2018-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-11-30

Study Completion Date

2020-12-31

Brief Summary

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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.

Detailed Description

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* Patient information and collection of a signed informed consent form
* Clinical data collection
* Blood samples of 5 mL:

1. after registration, prior to the first fraction of radiotherapy
2. during radiotherapy sessions
3. one month, 3 months after the last radiotherapy session
* Storage of the blood samples at ambient temperature
* Transportation of the samples to the Institute of Biology of Lille (IBL) - CNRS UMR8161 for analysis
* Destruction of the samples at the end of the analysis

Conditions

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Neoplasms

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Tongren Hospital

OTHER

Sponsor Role collaborator

Peking University First Hospital

OTHER

Sponsor Role lead

Responsible Party

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Celia

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gao Xianshu, Master

Role: STUDY_CHAIR

Peking University First Hospital

Locations

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Peking University First Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Bai Yun, Master

Role: CONTACT

Facility Contacts

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Gao Xianshu, Master

Role: primary

Other Identifiers

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20161022

Identifier Type: -

Identifier Source: org_study_id

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