NeoplasmsTRHRNCT02854449
Tumor Response in Hypofractionated Radiotherapy
An observational study of Neoplasms, run by Peking University First Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Nov 2016to Dec 2020
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients receive local hypofractionated radiotherapy
Who may be able to join
- Patient requiring a hypofractionated irradiation;
- pathologically confirmed Unspecified Adult Solid Tumor
- Age ≥ 18 years old
- KPS≥70
- Signed written informed consent.
Who cannot join
- Patient treated by chemotherapy, targeted or immunotherapy within 21 days before the first sampling,
- Pregnant or breastfeeding woman,
- Patient under guardianship or tutorship.
Trial locations and contacts
1 site in 1 country.
Bai Yun, Master contact
China1 site, 1 recruiting
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality
Gao Xianshu, Master, gao7777@139.com
About this study
Official title: Biomarkers of Tumor Response in Hypofractionated Radiotherapy
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.
Read the detailed description
- Patient information and collection of a signed informed consent form
- Clinical data collection
- Blood samples of 5 mL:
- after registration, prior to the first fraction of radiotherapy
- during radiotherapy sessions
- 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
- Neoplasms
- Keywords
- Immune Marker, Immunologic Marker, Radiotherapy, Dose Hypofractionation
- Medical subject headings
- Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of immune cells
The primary endpoint is the change of the percentage of immune cells before, during and after radiotherapy
Measured: 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
Local control of radiotherapy will be assessed based on Response Evaluation Criteria in Solid Tumors(RECIST)1.1
Measured: 3 months
Acute and Late toxicities
Acute and late toxicities will be assessed based on the common toxicity criteria for adverse events version 4.0 (CTCAEv4.0).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2016 (estimated)
- Study startNov 2016
- Primary completionDec 2019 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Tongren Hospital
- Responsible party
- Principal investigator, Celia, Peking University First Hospital
- Investigators
- Gao Xianshu, Master, Study chair, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02854449
- Sponsor's protocol ID
- 20161022
- Acronym
- TRHR
- Status last verified
- Apr 2018
- First submitted
- 1 Aug 2016
- Last updated
- 20 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers of Tumor Response in Hypofractionated Radiotherapy
- ClinicalTrials.gov ID
- NCT02854449
- Acronym / sponsor ID
- TRHR / 20161022
- Conditions
- Neoplasms
- Keywords
- Immune Marker, Immunologic Marker, Radiotherapy, Dose Hypofractionation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Collaborators
- Beijing Tongren Hospital
- Study start
- Nov 2016 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 3 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Patient information and collection of a signed informed consent form
- Clinical data collection
- Blood samples of 5 mL:
- after registration, prior to the first fraction of radiotherapy
- during radiotherapy sessions
- 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
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receive local hypofractionated radiotherapy
Key inclusion criteria (5 listed)
- Patient requiring a hypofractionated irradiation;
- pathologically confirmed Unspecified Adult Solid Tumor
- Age ≥ 18 years old
- KPS≥70
- Signed written informed consent.
Key exclusion criteria (3 listed)
- Patient treated by chemotherapy, targeted or immunotherapy within 21 days before the first sampling,
- Pregnant or breastfeeding woman,
- Patient under guardianship or tutorship.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of immune cells
Time frame: 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
The primary endpoint is the change of the percentage of immune cells before, during and after radiotherapy
2 secondary outcomes
Local control
Time frame: 3 months
Acute and Late toxicities
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2018.
- Individual participant dataSharing planned: No
Related trials for Neoplasms
Not yet recruitingPhase 1/2
177Lu-DOTA-EB-TATE in Adult Patients With Metastatic, Radioactive Iodine Non-Responsive Oncocytic (Hurthle-Cell) Thyroid Cancer
Thyroid Cancer
RecruitingPhase 1/2
A Clinical Study of MK-2870 Alone or With Other Treatments to Treat Gastrointestinal Cancers (MK-9999-02A)
Colorectal Cancer, Pancreatic Ductal Adenocarcinoma
RecruitingPhase 3
A Study of Raludotatug Deruxtecan With or Without Bevacizumab as First-Line Maintenance Treatment in Non-HRD-Positive Advanced Ovarian Cancer (MK-5909-006, (ENGOT-ov102/GOG-3141/ REJOICE-Ovarian 04)
Ovarian Cancer, Ovarian Neoplasms
RecruitingPhase 1/2
Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (ViPOR) in Relapsed/Refractory B-cell Lymphoma
Lymphoma, Non-Hodgkin Lymphoma
RecruitingPhase 3
Pivotal Open-label Phase 3 Clinical Study of QTX-2101 in Adult Patients With Acute Promyelocytic Leukemia
Acute Promyelocytic Leukemia (APL), Acute Promyelocytic Leukaemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bai Yun, Master contact
Gao Xianshu, Master study chair
Peking University First Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neoplasms, run by Peking University First Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bai Yun, Master (flkmy1@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of immune cells (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2018.