NSCLCNCT04522687
Influence of Radiotherapy and Chemotherapy in the Value of Peripheral Blood Lymphocyte Subsets Among Thoracic Cancer
An observational study of NSCLC and Esophageal Squamous Cell Carcinoma, run by Shanghai Cancer Hospital, China at 1 site in China.
Trial summary
This study is an observation, single center study to evaluate the alternations and prognostic value of peripheral blood lymphocyte (PBL) in patients diagnosed with thoracic cancers, including lung cancer, esophageal squamous cell carcinoma and thymic epithelial carcinoma underwent radiotherapy with or without… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC, Esophageal Squamous Cell Carcinoma, Thymic Epithelial Tumor
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2012to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Chinese patients diagnosed with NSCLC, esophageal squamous cell carcinoma or thymic epithelial tumor.
Who may be able to join
- Age at least 18 years. ECOG PS 0-1. Pathologically confirmed NSCLC, esophageal squamous cell carcinoma or thymic epithelial tumor.
- Life expectancy of more than 3 months. Patients with no indications for palliative radiotherapy in the opinion of the investigator.
- Patients with a prior history of surgery are eligible if they have recovered adequately from the toxicity and/or complications of surgery.
- Signed informed consent for the use of fresh tumor biopsies before and during the treatment.
- Women of childbearing age and men must agree to use effective contraception during the trial.
- Adequate organ function within 1 week prior to the enrollment：
Show all 9Show fewer
- Adequate bone marrow function: hemoglobin ≥80g/L, white blood cell (WBC) count ≥ 4.0 * 10 ^ 9/L or neutrophil count ≥ 1.5 * 10 ^ 9/L, and platelet count ≥ 100 * 10 ^ 9/L;
- Adequate hepatic function: total bilirubin < 1.5 x upper limit of normal (ULN). Note: If total bilirubin is > 1.5 x ULN, direct bilirubin must ≤ ULN, Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤2.5 ULN;
- Adequate renal function: serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 50 mL/min;
Who cannot join
- Pregnant or lactating women. History of any other malignancy. Patients in whom palliative radiotherapy is indicated in the opinion of the investigator.
- Active infection, congestive heart failure, myocardial infarction within the 6 months prior to enrollment, unstable angina pectoris or cardiac arrhythmia.
- Patients who have received tumor vaccine; or administration of live, attenuated vaccine within 4 weeks before the start of treatment.
- Mental disorders, drug abuse, and social condition that may negatively impact compliance in the opinion of the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Min Fan, MD, 18017312298, fanming@fudan.edu.cn
About this study
Official title: Observation of the Impact of Radiotherapy With or Without Chemotherapy in the Value of Peripheral Blood Lymphocyte Subsets for Patients With Thoracic Cancer
This study is an observation, single center study to evaluate the alternations and prognostic value of peripheral blood lymphocyte (PBL) in patients diagnosed with thoracic cancers, including lung cancer, esophageal squamous cell carcinoma and thymic epithelial carcinoma underwent radiotherapy with or without chemotherapy.
- Medical subject headings
- Esophageal Squamous Cell Carcinoma, Thymic epithelial tumor
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
OS was defined as the time from the date of enrollment until death by any cause. Participants still alive at the time of data analysis were censored at the date of last follow-up.
Measured: Five years
Secondary outcomes (1)
Progression Free Survival
PFS was measured from the date of enrollment to the date of disease progression as defined by Response Evaluation Criteria in Solid Tumor (RECIST) Version 1.1 or death due to any cause, whichever occurred first
Measured: Five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2020
- Study start1 Jan 2012
- Primary completionDec 2023 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Cancer Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fan Min, Shanghai Cancer Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04522687
- Sponsor's protocol ID
- SHCH1501
- Status last verified
- Aug 2020
- First submitted
- 19 Aug 2020
- Last updated
- 21 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observation of the Impact of Radiotherapy With or Without Chemotherapy in the Value of Peripheral Blood Lymphocyte Subsets for Patients With Thoracic Cancer
- ClinicalTrials.gov ID
- NCT04522687
- Acronym / sponsor ID
- SHCH1501
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Shanghai Cancer Hospital, ChinaUniversity, hospital or other
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 21 Aug 2020 (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.
This study is an observation, single center study to evaluate the alternations and prognostic value of peripheral blood lymphocyte (PBL) in patients diagnosed with thoracic cancers, including lung cancer, esophageal squamous cell carcinoma and thymic epithelial carcinoma underwent radiotherapy with or without chemotherapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chinese patients diagnosed with NSCLC, esophageal squamous cell carcinoma or thymic epithelial tumor.
Key inclusion criteria (9 listed)
- Age at least 18 years. ECOG PS 0-1. Pathologically confirmed NSCLC, esophageal squamous cell carcinoma or thymic epithelial tumor.
- Life expectancy of more than 3 months. Patients with no indications for palliative radiotherapy in the opinion of the investigator.
- Patients with a prior history of surgery are eligible if they have recovered adequately from the toxicity and/or complications of surgery.
- Signed informed consent for the use of fresh tumor biopsies before and during the treatment.
- Women of childbearing age and men must agree to use effective contraception during the trial.
Key exclusion criteria (4 listed)
- Pregnant or lactating women. History of any other malignancy. Patients in whom palliative radiotherapy is indicated in the opinion of the investigator.
- Active infection, congestive heart failure, myocardial infarction within the 6 months prior to enrollment, unstable angina pectoris or cardiac arrhythmia.
- Patients who have received tumor vaccine; or administration of live, attenuated vaccine within 4 weeks before the start of treatment.
- Mental disorders, drug abuse, and social condition that may negatively impact compliance in the opinion of the investigator.
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
Overall Survival
Time frame: Five years
OS was defined as the time from the date of enrollment until death by any cause. Participants still alive at the time of data analysis were censored at the date of last follow-up.
1 secondary outcome
Progression Free Survival
Time frame: Five years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2020.
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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.
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 NSCLC and Esophageal Squamous Cell Carcinoma, run by Shanghai Cancer Hospital, China 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 9 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 21 Aug 2020. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: Five years). 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 21 Aug 2020.