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Monitoring Efficacy of Radiotherapy in Lung Cancer and Esophageal Cancer
Lung cancer, one of the malignant tumors which poses a threat to human's health, has increased morbidity and mortality recently. Radiotherapy, as one of the common treatments, has important value in clinical application. Esophageal cancer, one of the most common digestive system cancers, has poor prognosis and high mortality. Esophageal cancer has high aggressive and many patients can't get surgical treatment because of the tumor metastasis at the time of diagnosis.Currently, chemoradiotherapy has become one of the standard treatment regimens for patients with unresectable esophageal cancer in National Comprehensive Cancer Network(NCCN). So radiotherapy is one of the most important treatments in esophageal cancer.
Currently, the efficacy evaluation method of radiotherapy is by imaging examination after several courses of treatment. However, new reports suggest that circulating tumor DNA(ctDNA) has the potential to be an indicator of therapeutic effectiveness and recurrence risk.
| Condition or disease |
|---|
| Lung Cancer Esophageal Cancer |
Circulating free DNA (cfDNA) can be found dissolved in plasma and serum, at variable amounts. In the case of cancer patients, ctDNA is a fraction of the cfDNA derived from tumor. Currently, the ctDNA is widely used in "liquid biopsy" for not only does it carry the same somatic alterations as the tumor itself but also its percentage is correlated with tumor burden.
This study will investigate the clinical value of efficacy evaluation and prognosis of ctDNA detecting technique in patients with radiotherapy.
| Study Type : | Observational |
| Estimated Enrollment : | 150 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Monitoring Efficacy of Radiotherapy Based on Next Generation Sequencing Liquid Biopsy Technique in Lung Cancer and Esophageal Cancer: a Prospective Study |
| Actual Study Start Date : | February 1, 2019 |
| Estimated Primary Completion Date : | June 30, 2022 |
| Estimated Study Completion Date : | December 1, 2022 |
| Group/Cohort |
|---|
|
patients with radiotherapy
The patients of lung cancer or esophagueal cancer, who received definitvie RT, should included in this Cohort.
|
- progression free survival [ Time Frame: 3 years ]the rate of progression free survival for 3 years
- overall survival [ Time Frame: 3 years ]the rate of overall survival for 3 years
- Adverse Events [ Time Frame: 3 years ]Number of Participants with Adverse Events
Biospecimen Retention: Samples With DNA
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Patients with histopathological proved lung cancer or esophageal cancer.
- Candidate for radiotherapy.
- No history of prior anti-tumor treatment.
- Eastern Cooperative Oncology Group (ECOG) score 0,1.
- Being able to receive computed tomography (CT) and magnetic resonance imaging (MRI).
- Blood sample is available for dynamic monitoring.
- Written informed consent provided.
- Good compliance in the follow-up.
Exclusion Criteria:
- Had received radiotherapy, chemotherapy, biotherapy or other treatment that is related to lung cancer or esophageal cancer.
- The patients have the sign of any serious or uncontrolled systematic diseases that may have significant impact on the balance between risk and benefit, such as hypertension, infection of hepatitis B, hepatitis C or human immunodeficiency virus(HIV).
- With history of alcohol or drug abuse.
| Contact: Nan Bi, Doctor | 8613520445135 | binan_email@163.com | |
| Contact: Tao Zhang, Professor | 8618911006677 | zhangt10@126.com |
| China, Beijing | |
| Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical sciences | Recruiting |
| Beijing, Beijing, China, 100021 | |
| Contact: Department of Radiation Oncology | |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | July 9, 2019 | ||||||||
| First Posted Date | July 10, 2019 | ||||||||
| Last Update Posted Date | February 2, 2021 | ||||||||
| Actual Study Start Date | February 1, 2019 | ||||||||
| Estimated Primary Completion Date | June 30, 2022 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
progression free survival [ Time Frame: 3 years ] the rate of progression free survival for 3 years
|
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| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures |
|
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| Original Secondary Outcome Measures | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | Monitoring Efficacy of Radiotherapy in Lung Cancer and Esophageal Cancer | ||||||||
| Official Title | Monitoring Efficacy of Radiotherapy Based on Next Generation Sequencing Liquid Biopsy Technique in Lung Cancer and Esophageal Cancer: a Prospective Study | ||||||||
| Brief Summary |
Lung cancer, one of the malignant tumors which poses a threat to human's health, has increased morbidity and mortality recently. Radiotherapy, as one of the common treatments, has important value in clinical application. Esophageal cancer, one of the most common digestive system cancers, has poor prognosis and high mortality. Esophageal cancer has high aggressive and many patients can't get surgical treatment because of the tumor metastasis at the time of diagnosis.Currently, chemoradiotherapy has become one of the standard treatment regimens for patients with unresectable esophageal cancer in National Comprehensive Cancer Network(NCCN). So radiotherapy is one of the most important treatments in esophageal cancer. Currently, the efficacy evaluation method of radiotherapy is by imaging examination after several courses of treatment. However, new reports suggest that circulating tumor DNA(ctDNA) has the potential to be an indicator of therapeutic effectiveness and recurrence risk. |
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| Detailed Description |
Circulating free DNA (cfDNA) can be found dissolved in plasma and serum, at variable amounts. In the case of cancer patients, ctDNA is a fraction of the cfDNA derived from tumor. Currently, the ctDNA is widely used in "liquid biopsy" for not only does it carry the same somatic alterations as the tumor itself but also its percentage is correlated with tumor burden. This study will investigate the clinical value of efficacy evaluation and prognosis of ctDNA detecting technique in patients with radiotherapy. |
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| Study Type | Observational | ||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples With DNA Description:
plasma
|
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| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | patients with lung cancer or esophageal cancer intend to receive radiotherapy in Cancer hospital,Chinese academy of medical sciences. | ||||||||
| Condition |
|
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| Intervention | Not Provided | ||||||||
| Study Groups/Cohorts | patients with radiotherapy
The patients of lung cancer or esophagueal cancer, who received definitvie RT, should included in this Cohort.
|
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
150 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | December 1, 2022 | ||||||||
| Estimated Primary Completion Date | June 30, 2022 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
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| Listed Location Countries | China | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT04014465 | ||||||||
| Other Study ID Numbers | NCC1923 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Tao Zhang, Chinese Academy of Medical Sciences | ||||||||
| Study Sponsor | Chinese Academy of Medical Sciences | ||||||||
| Collaborators | Not Provided | ||||||||
| Investigators | Not Provided | ||||||||
| PRS Account | Chinese Academy of Medical Sciences | ||||||||
| Verification Date | January 2021 | ||||||||
