Non-small Cell Lung CancerNCT03337711
Explore Intra-tumor Heterogeneity and Prognostic Value of Postoperative Blood ctDNA of ⅡA - ⅢA Stage Non-squamous NSCLC Based on the Capture-based Sequencing and UMI Technology of Burning Rock
An observational study of Non-small Cell Lung Cancer, run by Sun Yat-sen University at 1 site in China.
Trial summary
The study will collect 100 ⅡA - ⅢA stage non-squamous NSCLC tumor tissue and blood specimens (Include: (1) tissue by operation: 3 specimens from different regions of each patient; (2) Blood: preoperative blood (within one week), postoperative blood (3-4 weeks after operation (before adjuvant chemotherapy), 20 weeks… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-small Cell Lung Cancer
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 24 May 2017to 31 May 2020
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with postoperative pathologic staging diagnosis of ⅡA to ⅢA non-squamous NSCLC period
Who may be able to join
- Received radical surgical treatment and postoperative pathological had pointed out non-squamous NSCLC;
- Patients with postoperative pathologic staging diagnosis of Ⅱ A - Ⅲ A period (AJCC TNM staging (version 8));
- Female or male Age ≥ 18 years and ≤ 75;
- Did not receive any of the anti-tumor treatment for current disease, such as radiation therapy, chemotherapy, or molecular target, etc;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0/1；
- The expect survival time is more than 6 months;
- Screening laboratory results:
- Hematological:Absolute Neutrophil Count (ANC) ≥ 1500 K/mm^3 (without use of G-CSF 4 weeks prior to enrollment);Hemoglobin (Hgb) ≥ 9 g/dL (transfusions allowed);Platelets (Plts) ≥ 100 k/mm^3; (2) Hepatic:Bilirubin ≤1.5×upper limit of normal (ULN),Aspartate aminotransferase (AST) ≤2.5 × ULN, ≤ 5 x ULN if liver metastases are present;Alanine aminotransferase (ALT) ≤ 2.5 × ULN, ≤ 5 x ULN if liver metastases are present; (3) Renal:Cr≤ 1.5 x ULN or Ccr≥ 50 mL/min, and Urine dipstick test result show urinary protein < 2+. The urinary protein ≥ 2 + should be 24-hour urine collection and ensure 24 hours urine protein content < 1 g; 8. Patients agreed and have the ability to follow the study plan to be visited, agreed to provide blood specimens in the process of preoperative (within one week) and postoperative (3-4 weeks, 20 weeks and 1 year after surgery) and tumor tissue specimens by operation, and cooperate with other research steps.
Who cannot join
- Second primary malignancy, other than cervical carcinoma in situ after adequate treatment, in situ malignancies or adequately treated basal cell carcinoma of the skin, localized prostate cancer after radical surgery, ductal carcinoma in situ after radical surgery;
- Clinical evaluation for patients with inoperable;
- A serious uncontrolled medical disorder or active infection that in the investigator's opinion would impair the participant's ability to receive study treatment;
- Prior therapy with surgery, chemotherapy, targeted therapy and immunotherapy is not allowed;
- Eastern Cooperative Oncology Group performance status(ECOG PS ) ≥2;
- A definite clinical active infection, including but not limited to pneumonia;
- Other situation the researchers think that doesn't fit into the group.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-Sen university cancer center
Guangzhou, Guangdong, 510000
Hao Long, Prof, +86 2087343261, longhao@sysucc.org.cn
Ruping Xing, +86 2087343736, xingrp@sysucc.org.cn
About this study
Official title: A Open Multicenter Clinical Study to Explore Intra-tumor Heterogeneity and Prognostic Value of Postoperative Blood ctDNA of ⅡA - ⅢA Stage Non-squamous NSCLC Based on the Capture-based Sequencing and UMI (Unique Molecular Identifier) Technology of Burning Rock
The study will collect 100 ⅡA - ⅢA stage non-squamous NSCLC tumor tissue and blood specimens (Include: (1) tissue by operation: 3 specimens from different regions of each patient; (2) Blood: preoperative blood (within one week), postoperative blood (3-4 weeks after operation (before adjuvant chemotherapy), 20 weeks after operation (1 month after adjuvant chemotherapy), 1 year after operation). Capture-based sequencing(168 genes panel +UMI) will performed. All patients are recommended for "pemetrexed combined platinum" adjuvant chemotherapy for 4 cycles(Moderate-dose Chemotherapy) 3-4 weeks after operation. The clinical data should be collected until disease progression. The relationship of postoperative ctDNA and recurrence defined by clinical imaging will be analyzed, as well as the correlation of tissue and postoperative blood NGS results.
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- NSCLC;ctDNA;IIA-IIIA
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence or metastasis
The patient was diagnosed as recurrence or metastasis according to the computed tomography (CT) scan
Measured: two years after the last patient entered the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2017
- Study start24 May 2017
- Primary completion31 May 2020 (estimated)
- Study completion31 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hao Long, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03337711
- Sponsor's protocol ID
- A2017-001
- Status last verified
- Nov 2017
- First submitted
- 6 Nov 2017
- Last updated
- 9 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Open Multicenter Clinical Study to Explore Intra-tumor Heterogeneity and Prognostic Value of Postoperative Blood ctDNA of ⅡA - ⅢA Stage Non-squamous NSCLC Based on the Capture-based Sequencing and UMI (Unique Molecular Identifier) Technology of Burning Rock
- ClinicalTrials.gov ID
- NCT03337711
- Acronym / sponsor ID
- A2017-001
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- NSCLC;ctDNA;IIA-IIIA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 24 May 2017 (actual)
- Primary completion
- 31 May 2020 (estimated)
- Study completion
- 31 May 2020 (estimated)
- First posted
- 9 Nov 2017 (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.
The study will collect 100 ⅡA - ⅢA stage non-squamous NSCLC tumor tissue and blood specimens (Include: (1) tissue by operation: 3 specimens from different regions of each patient; (2) Blood: preoperative blood (within one week), postoperative blood (3-4 weeks after operation (before adjuvant chemotherapy), 20 weeks after operation (1 month after adjuvant chemotherapy), 1 year after operation). Capture-based sequencing(168 genes panel +UMI) will performed. All patients are recommended for "pemetrexed combined platinum" adjuvant chemotherapy for 4 cycles(Moderate-dose Chemotherapy) 3-4 weeks after operation. The clinical data should be collected until disease progression. The relationship of postoperative ctDNA and recurrence defined by clinical imaging will be analyzed, as well as the correlation of tissue and postoperative blood NGS results.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with postoperative pathologic staging diagnosis of ⅡA to ⅢA non-squamous NSCLC period
Key inclusion criteria (8 listed)
- Received radical surgical treatment and postoperative pathological had pointed out non-squamous NSCLC;
- Patients with postoperative pathologic staging diagnosis of Ⅱ A - Ⅲ A period (AJCC TNM staging (version 8));
- Female or male Age ≥ 18 years and ≤ 75;
- Did not receive any of the anti-tumor treatment for current disease, such as radiation therapy, chemotherapy, or molecular target, etc;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0/1；
Key exclusion criteria (7 listed)
- Second primary malignancy, other than cervical carcinoma in situ after adequate treatment, in situ malignancies or adequately treated basal cell carcinoma of the skin, localized prostate cancer after radical surgery, ductal carcinoma in situ after radical surgery;
- Clinical evaluation for patients with inoperable;
- A serious uncontrolled medical disorder or active infection that in the investigator's opinion would impair the participant's ability to receive study treatment;
- Prior therapy with surgery, chemotherapy, targeted therapy and immunotherapy is not allowed;
- Eastern Cooperative Oncology Group performance status(ECOG PS ) ≥2;
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
recurrence or metastasis
Time frame: two years after the last patient entered the study
The patient was diagnosed as recurrence or metastasis according to the computed tomography (CT) scan
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2017.
- Individual participant dataSharing planned: Undecided
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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.
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 Non-small Cell Lung Cancer, run by Sun Yat-sen University 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 8 inclusion and 7 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 9 Nov 2017. 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 Hao Long, Prof (+86 20 87343261, longhao@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recurrence or metastasis (time frame: two years after the last patient entered the study). 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 9 Nov 2017.