Carcinoma, Non-Small-Cell LungPOLICENCT01740804
Dynamic Circulating Tumor Cell (CTC) Changes During the Chemotherapy in NSCLC
An observational study of Carcinoma, Non-Small-Cell Lung and Cell, Circulating Tumor, run by Guangdong Association of Clinical Trials at 1 site in China.
Trial summary
Primary endpoint To observe the dynamic changes of CTC during the process of platinum based chemotherapy in advanced NSCLC. To study the relationship between CTC count and clinical outcome of chemotherapy (ORR and PFS). Secondary endpoint To study the relationship between CTC and overall survival. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung, Cell, Circulating Tumor
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- Nov 2012to Jun 2016
- 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: Advanced NSCLC (stage IIIb/IV or recurrent NSCLC)
Who may be able to join
- Patients with histologically documented, locally advanced or recurrent (stage IIIb and not amenable or combined modality treatment) or metastatic (stage IV) non-small cell lung cancer.
- ECOG performance status of ≤ 2.
- Patients without prior chemotherapy or therapy with systemic anti-neoplastic therapy. Previous adjuvant or neo-adjuvant treatment or combine chemoradiotherapy for stage I to III is permitted if completed > 12 months before enrollment.
- According to routine first line doublet chemotherapy in clinical practice, Cisplatin or carboplatin combined with gemcitabine or paclitaxel or docetaxol or Vinorelbine were recommended.
- Patients must have measurable disease according to the RECIST (version 1.1) criteria.
- Life expectancy of at least 12 weeks.
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- Age ≥ 18 years.
- Written (signed) informed Consent to participate in the study.
- Adequate organ function as defined by the following criteria:Liver function: SGOT (AST) and SGPT (ALT) ≤ 2.5 X ULN in the absence of liver metastases or up to 5 X ULN in case of liver metastases. Total bilirubin ≤ 1.5ULN.Bone marrow function: Granulocyte count ≥ 1,500/mm3 and platelet count ≥100,000/mm3 and hemoglobin ≥90g/dl. Renal function: serum creatinine ≤ 1.5 ULN or creatinine clearance ≥ 60 ml/min. (based on modified Cockcroft-Gault formula).
- For all females of childbearing potential a negative serum/urine pregnancy test must be obtained within 48 hours before enrollment. Postmenopausal women must have been amenorrhoeic for at least 12 months to be considered of non-childbearing potential.
Who cannot join
- Patients with prior chemotherapy or therapy with systemic anti-cancer therapy including target therapy. Previous adjuvant or neo-adjuvant treatment for non-metastatic disease is permitted if completed ≥ 6 months before the enrollments.
- Patients with history of any other malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer).
- Patients who have brain metastasis or spinal cord compression. It is permitted if the patient has been treated with surgery and/or radiation with evidence of stable disease for at least 4 weeks.
- Patients who are at risk (in the investigator's opinion) of transmitting human immunodeficiency virus (HIV) through blood or other body fluids.
- Nursing or lactating women.
- Sexually active males and females (of childbearing potential) unwilling to practice contraception during the study.
- Unwilling to write informed consent to participate in the study.
- Patients who is unwilling to accept the follow-up.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Observational Study on the Dynamic Changes of CTC Enumeration in Advanced NSCLC With 1st Line Chemotherapy
Primary endpoint To observe the dynamic changes of CTC during the process of platinum based chemotherapy in advanced NSCLC.
To study the relationship between CTC count and clinical outcome of chemotherapy (ORR and PFS).
Secondary endpoint To study the relationship between CTC and overall survival. To study the molecular feature of CTC, such as epidermal growth factor receptor (EGFR), KRAS, CD117, etc.
Read the detailed description
This is a prospective observational non-intervention study evaluating the dynamic CTC count during the chemotherapy. Patients provide written informed consent and pass the screening. Peripheral blood will be drawn before and after the first line chemotherapy. Analyze the relationship between CTC count and clinical outcome. The time points of blood drawing are set as following: once prior to 1st cycle of chemotherapy, once 1 week prior to 2nd cycle of chemotherapy, posterior to 4th cycle (or less than 4th cycle) of chemotherapy and once when progressive disease (PD). The specific blood tube CellSave Tube will be used, 7.5ml blood sample every time. One follow-up (including by phone) be made every 3 month after PD until death. The clinical outcome of first line chemotherapy will be ultimately obtained.
- Keywords
- Circulating tumor cell, Non-small cell lung cancer, chemotherapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Neoplastic Cells, Circulating
What is being measured
The primary outcome is the main question the study is designed to answer.
dynamic CTC changes during chemotherapy
Measured: baseline, 3 weeks and up to progression disease of chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2012 (estimated)
- Study startNov 2012
- Primary completionApr 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, Non-Small-Cell LungStudies 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
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangdong Association of Clinical Trials
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yi-Long Wu, MD, Principal investigator, Guangdong General Hospital & Guangdong Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01740804
- Sponsor's protocol ID
- CTONG1202
- Acronym
- POLICE
- Status last verified
- Sep 2015
- First submitted
- 27 Nov 2012
- Last updated
- 5 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wang Z, Zhang XC, Feng WN, Zhang L, Liu XQ, Guo WB, Deng YM, Zou QF, Yang JJ, Zhou Q, Wang BC, Chen HJ, Tu HY, Yan HH, Wu YL. Circulating tumor cells dynamics during chemotherapy predict survival and response in advanced non-small-cell lung cancer patients. Ther Adv Med Oncol. 2023 Apr 22;15:17588359231167818. doi: 10.1177/17588359231167818. eCollection 2023.
PubMed 37113733
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study on the Dynamic Changes of CTC Enumeration in Advanced NSCLC With 1st Line Chemotherapy
- ClinicalTrials.gov ID
- NCT01740804
- Acronym / sponsor ID
- POLICE / CTONG1202
- Keywords
- Circulating tumor cell, Non-small cell lung cancer, chemotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Guangdong Association of Clinical TrialsUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Apr 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 4 Dec 2012 (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.
Primary endpoint To observe the dynamic changes of CTC during the process of platinum based chemotherapy in advanced NSCLC.
To study the relationship between CTC count and clinical outcome of chemotherapy (ORR and PFS).
Secondary endpoint To study the relationship between CTC and overall survival. To study the molecular feature of CTC, such as epidermal growth factor receptor (EGFR), KRAS, CD117, etc.
Detailed description
This is a prospective observational non-intervention study evaluating the dynamic CTC count during the chemotherapy. Patients provide written informed consent and pass the screening. Peripheral blood will be drawn before and after the first line chemotherapy. Analyze the relationship between CTC count and clinical outcome. The time points of blood drawing are set as following: once prior to 1st cycle of chemotherapy, once 1 week prior to 2nd cycle of chemotherapy, posterior to 4th cycle (or less than 4th cycle) of chemotherapy and once when progressive disease (PD). The specific blood tube CellSave Tube will be used, 7.5ml blood sample every time. One follow-up (including by phone) be made every 3 month after PD until death. The clinical outcome of first line chemotherapy will be ultimately obtained.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Advanced NSCLC (stage IIIb/IV or recurrent NSCLC)
Key inclusion criteria (10 listed)
- Patients with histologically documented, locally advanced or recurrent (stage IIIb and not amenable or combined modality treatment) or metastatic (stage IV) non-small cell lung cancer.
- ECOG performance status of ≤ 2.
- Patients without prior chemotherapy or therapy with systemic anti-neoplastic therapy. Previous adjuvant or neo-adjuvant treatment or combine chemoradiotherapy for stage I to III is permitted if completed > 12 months before enrollment.
- According to routine first line doublet chemotherapy in clinical practice, Cisplatin or carboplatin combined with gemcitabine or paclitaxel or docetaxol or Vinorelbine were recommended.
- Patients must have measurable disease according to the RECIST (version 1.1) criteria.
Key exclusion criteria (8 listed)
- Patients with prior chemotherapy or therapy with systemic anti-cancer therapy including target therapy. Previous adjuvant or neo-adjuvant treatment for non-metastatic disease is permitted if completed ≥ 6 months before the enrollments.
- Patients with history of any other malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer).
- Patients who have brain metastasis or spinal cord compression. It is permitted if the patient has been treated with surgery and/or radiation with evidence of stable disease for at least 4 weeks.
- Patients who are at risk (in the investigator's opinion) of transmitting human immunodeficiency virus (HIV) through blood or other body fluids.
- Nursing or lactating women.
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
dynamic CTC changes during chemotherapy
Time frame: baseline, 3 weeks and up to progression disease of chemotherapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2016.
- Derived from this study: PubMed 37113733Wang Z, Zhang XC, Feng WN, Zhang L, Liu XQ, Guo WB, Deng YM, Zou QF, Yang JJ, Zhou Q, Wang BC, Chen HJ, Tu HY, Yan HH, Wu YL. Circulating tumor cells dynamics during chemotherapy predict survival and response in advanced non-small-cell lung cancer patients. Ther Adv Med Oncol. 2023 Apr 22;15:17588359231167818. doi: 10.1177/17588359231167818. eCollection 2023.
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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.
Yi-Long Wu, MD principal investigator
Guangdong General Hospital & Guangdong Academy of Medical Sciences
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 Carcinoma, Non-Small-Cell Lung and Cell, Circulating Tumor, run by Guangdong Association of Clinical Trials 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 10 inclusion and 8 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: finished, as of the sponsor's last update on 5 Dec 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
dynamic CTC changes during chemotherapy (time frame: baseline, 3 weeks and up to progression disease of chemotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01740804, which also lists 1 linked publication.
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 5 Dec 2016.