Radiation ToxicityNCT04110223
Validation Studies of Biomarkers for Precision Radiation Oncology in Locally Advanced Solid Tumors
An observational study of Radiation Toxicity and Advanced Cancer, run by Shandong Cancer Hospital and Institute at 1 site in China.
Trial summary
Despite the common application of radiotherapy in cancer treatment, the prediction of radiosensitivity and treatment response has not yet entered the era of precision medicine. Therefore, development of genome-based methods for predicting radiosensitivity and treatment response is a central goal of radiation oncology. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiation Toxicity, Advanced Cancer, Radiosensitivity
- What is being tested?
- next generation sequence
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 8 Oct 2018to 8 Oct 2021
- How long will I take part?
- 2 Years
- 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 in the study with locally advanced solid tumors undergoing conventional fractionation or preoperative neoadjuvant radiotherapy (except stage IV patients and stage I patients to be treated with SBRT), including lung cancer, esophageal cancer, rectal cancer (neoadjuvant), cervical cancer, nasopharyngeal carcinoma and liver cancer
Who may be able to join
- Patients with locally advanced solid tumors (lung cancer, esophageal cancer, rectal cancer (neoadjuvant), cervical cancer, nasopharyngeal carcinoma cancer and liver cancer) identified by cytology and pathology;
- Patients need conventional fractionation and adequate radiotherapy;
- Age ≥ 18 years old, male and female;
- Expected survival time ≥ 12 weeks;
- PS score 0-2 within 2 weeks before admission to the group;
- There are tumor tissue samples and blood samples can be used for NGS inspection;
- Patients volunteered to join this study, sign informed consent, provide all diagnosis and treatment data after cancer diagnosis before entering the group, good compliance, cooperate with follow-up.
Who cannot join
- The patient's previous radiation therapy leads to overlapping potential fields;
- Stage IV patients and stage I patients to be treated with SBRT
- The patient cannot receive regular imaging examinations;
- Any serious or uncontrolled signs of systemic disease that the investigator believes may significantly affect the patient's risk/benefit balance, including hepatitis B, hepatitis C, and human immunodeficiency virus;
- The researcher believes that it is not suitable for the group.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shandong Cancer Hospital and Institute
Jinan, Shandong, 250117
Jinming Yu, 8653167626891
About this study
Despite the common application of radiotherapy in cancer treatment, the prediction of radiosensitivity and treatment response has not yet entered the era of precision medicine. Therefore, development of genome-based methods for predicting radiosensitivity and treatment response is a central goal of radiation oncology. In the previous study, the investigators have identified a set of novel potential biomarkers associated with radiosensitivity and recurrence，through correlating patients' genomic profiles with toxicity, disease progression and overall survival after RT.
Read the detailed description
Researchers have long recognized that individual differences in sensitivity to radiation are caused by genetic variations and implicated multiple key pathways that might explain radiation toxicity. Normal tissue toxicity is a complex trait that involves the combined effect of a multitude of genes and pathways, and also dynamic interactions with the evolving cancer genome. The effect size of any individual factor is likely small. As a consequence, candidate gene approach and genome-wide association studies rarely lead to the identification of genetic determinants of radiation toxicity. Targeted next-generation sequencing (NGS), on the other hand, has become increasingly routine in the clinic and would allow simultaneous assessment of multiple genetic alterations.
- Conditions
- Radiation Toxicity, Advanced Cancer, Radiosensitivity
- Being tested
- next generation sequence
- Keywords
- radiotherapy, radiosensitivity, radiation toxity, NGS
- Medical subject headings
- Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
next generation sequenceGenetic
targeted NGS of patients' pretreatment tumor biopsy samples using a 474-gene panel, which covers cancer- and radio-sensitivity-related mutations and SNPs.
| Study group | Role | What they receive |
|---|---|---|
| non-smell cell lung cancer (NSCLC) | Advanced NSCLC patients receiving radiotherapy or chemo-radiotherapy Receives: Genetic: next generation sequence | |
| Rectal cancer | Rectal cancer patients receiving neoadjuvant radiotherapy or chemo-radiotherapy Receives: Genetic: next generation sequence | |
| Smell cell lung cancer (SCLC) | SCLC patients receiving radiotherapy or chemo-radiotherapy Receives: Genetic: next generation sequence | |
| Esophageal cancer | Esophageal cancer patients receiving radiotherapy or chemo-radiotherapy Receives: Genetic: next generation sequence | |
| Cervical cancer | Cervical cancer patients receiving radiotherapy or chemo-radiotherapy Receives: Genetic: next generation sequence | |
| Liver cancer | Liver cancer atients receiving radiotherapy or chemo-radiotherapy Receives: Genetic: next generation sequence |
What is being measured
The primary outcome is the main question the study is designed to answer.
TTP
Time to progression
Measured: 2 years
OS
Time to death
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2019
- Study start8 Oct 2018
- Primary completion8 Oct 2021 (estimated)
- Study completion8 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation ToxicityStudies 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
- Other
- Time perspective
- Other
- Enrolment
- 600 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Shandong Cancer Hospital and Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jinming Yu, Shandong Cancer Hospital and Institute
- Investigators
- Jinming Yu, Ph.D, Principal investigator, Shandong Cancer Hospital and Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04110223
- Sponsor's protocol ID
- GBRT-043
- Status last verified
- Sep 2019
- First submitted
- 12 Jun 2019
- Last updated
- 1 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation Studies of Biomarkers for Precision Radiation Oncology in Locally Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT04110223
- Acronym / sponsor ID
- GBRT-043
- Conditions
- Radiation Toxicity, Advanced Cancer, Radiosensitivity
- Keywords
- radiotherapy, radiosensitivity, radiation toxity, NGS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Shandong Cancer Hospital and InstituteUniversity, hospital or other
- Study start
- 8 Oct 2018 (actual)
- Primary completion
- 8 Oct 2021 (estimated)
- Study completion
- 8 Oct 2021 (estimated)
- First posted
- 1 Oct 2019 (actual)
- 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.
Despite the common application of radiotherapy in cancer treatment, the prediction of radiosensitivity and treatment response has not yet entered the era of precision medicine. Therefore, development of genome-based methods for predicting radiosensitivity and treatment response is a central goal of radiation oncology. In the previous study, the investigators have identified a set of novel potential biomarkers associated with radiosensitivity and recurrence，through correlating patients' genomic profiles with toxicity, disease progression and overall survival after RT.
Detailed description
Researchers have long recognized that individual differences in sensitivity to radiation are caused by genetic variations and implicated multiple key pathways that might explain radiation toxicity. Normal tissue toxicity is a complex trait that involves the combined effect of a multitude of genes and pathways, and also dynamic interactions with the evolving cancer genome. The effect size of any individual factor is likely small. As a consequence, candidate gene approach and genome-wide association studies rarely lead to the identification of genetic determinants of radiation toxicity. Targeted next-generation sequencing (NGS), on the other hand, has become increasingly routine in the clinic and would allow simultaneous assessment of multiple genetic alterations.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 2 Years
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| non-smell cell lung cancer (NSCLC) | – | Genetic: next generation sequenceAdvanced NSCLC patients receiving radiotherapy or chemo-radiotherapy |
| Rectal cancer | – | Genetic: next generation sequenceRectal cancer patients receiving neoadjuvant radiotherapy or chemo-radiotherapy |
| Smell cell lung cancer (SCLC) | – | Genetic: next generation sequenceSCLC patients receiving radiotherapy or chemo-radiotherapy |
| Esophageal cancer | – | Genetic: next generation sequenceEsophageal cancer patients receiving radiotherapy or chemo-radiotherapy |
| Cervical cancer | – | Genetic: next generation sequenceCervical cancer patients receiving radiotherapy or chemo-radiotherapy |
| Liver cancer | – | Genetic: next generation sequenceLiver cancer atients receiving radiotherapy or chemo-radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in the study with locally advanced solid tumors undergoing conventional fractionation or preoperative neoadjuvant radiotherapy (except stage IV patients and stage I patients to be treated with SBRT), including lung cancer, esophageal cancer, rectal cancer (neoadjuvant), cervical cancer, nasopharyngeal carcinoma and liver cancer
Key inclusion criteria (7 listed)
- Patients with locally advanced solid tumors (lung cancer, esophageal cancer, rectal cancer (neoadjuvant), cervical cancer, nasopharyngeal carcinoma cancer and liver cancer) identified by cytology and pathology;
- Patients need conventional fractionation and adequate radiotherapy;
- Age ≥ 18 years old, male and female;
- Expected survival time ≥ 12 weeks;
- PS score 0-2 within 2 weeks before admission to the group;
Key exclusion criteria (5 listed)
- The patient's previous radiation therapy leads to overlapping potential fields;
- Stage IV patients and stage I patients to be treated with SBRT
- The patient cannot receive regular imaging examinations;
- Any serious or uncontrolled signs of systemic disease that the investigator believes may significantly affect the patient's risk/benefit balance, including hepatitis B, hepatitis C, and human immunodeficiency virus;
- The researcher believes that it is not suitable for the group.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| next generation sequencetargeted NGS of patients' pretreatment tumor biopsy samples using a 474-gene panel, which covers cancer- and radio-sensitivity-related mutations and SNPs. | Genetic | Cervical cancer, Esophageal cancer, Liver cancer, Rectal cancer, Smell cell lung cancer (SCLC), non-smell cell lung cancer (NSCLC) |
Primary outcome
TTP
Time frame: 2 years
Time to progression
OS
Time frame: 2 years
Time to death
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2019.
- Individual participant dataSharing planned: No
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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.
Jinming Yu, Ph.D principal investigator
Shandong Cancer Hospital and Institute
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 Radiation Toxicity and Advanced Cancer, run by Shandong Cancer Hospital and Institute 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 7 inclusion and 5 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 1 Oct 2019. 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 Shuanghu Yuan Ph.D (+8613853106916, yuanshuanghu@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TTP (time frame: 2 years). The study lists 2 primary outcomes in all. 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 1 Oct 2019.