Lung NeoplasmsRIVALNCT03581708
Venous Thromboembolism in Advanced Lung Cancer
An observational study of Lung Neoplasms and Venous Thromboembolism, run by Guangdong Provincial People's Hospital at 1 site in China.
Trial summary
This is a prospective observatory clinical study, aiming to establish and validate venous thromboembolism risk model in Chinese advanced non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Neoplasms, Venous Thromboembolism
- What is being tested?
- lung cancer
- How many people
- 1,400 participants
- Where
- 1 siteChina
- Study dates
- Jul 2018to Jun 2022
- 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 diagnosed with advanced staged lung cancer with written informed consent.
Who may be able to join
- Age ≥ 18 years at the time of screening.
- Eastern Cooperative Oncology Group performance status of ≤ 2.
- Written informed consent obtained from the patient.
- Histologically and cytologically documented Stage 3B-4 lung cancer (according to Version 8 of the International Association for the Study of Lung Cancer Staging system).
- Patients with stage 1 to 3, who undergo radical therapy with disease free survival (DFS) >12 months.
- Willingness and ability to comply with scheduled visits and other study procedures.
Who cannot join
- History of another primary malignancy except for malignancy treated with curative intent with known active disease ≥ 5 years before date of the informed consent.
- Without signed informed consent.
- Unwillingness or inability to comply with scheduled visits or other study procedures.
- Previously diagnosed with VTE before signing informed consent.
Trial locations and contacts
1 site in 1 country.
China1 site
Guangdong General Hospital
Guangzhou, Guagndong, 510080
ZHEN WANG, PhD, 862083827812 ext. 50811, hunterol@163.com
XIAOLING CHEN, 862083827812 ext. 50812, chenxiaoling303@163.com
About this study
Official title: Real-world Study of the Incidence and Risk Factors of Venous Thromboembolism (VTE) in Chinese Advanced Stage Lung Cancer
This is a prospective observatory clinical study, aiming to establish and validate venous thromboembolism risk model in Chinese advanced non-small cell lung cancer.
Read the detailed description
VTE has high incidence in lung cancer and increases the mortality. Appropriate preventive measures contribute to 50% increase of incidence. The investigators are to investigate the VTE in advanced non-small cell lung cancer and delineate the risk factors to establish a VTE risk model system helping clinicians to differentiate VTE high risk population and apply early prevention in order to reduce the incidence of VTE.
- Conditions
- Lung Neoplasms, Venous Thromboembolism
- Being tested
- lung cancer
- Keywords
- lung cancer, Venous Thromboembolism
- Medical subject headings
- Lung Neoplasms, Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lung cancerOther
Also called advance lung cancer
If the patient is diagnosed with lung cancer in advanced stage, he/she will be followed up for VTE incidence
| Study group | Role | What they receive |
|---|---|---|
| advanced lung cancer | Patients diagnosed with advanced lung cancer Receives: Other: lung cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
VTE incidence risk evaluation
Real world VTE incidence risk evaluation in advanced lung cancer. Establish and validate VTE risk predictive model in Chinese advanced lung cancer.
Measured: 12 months
Secondary outcomes (2)
VTE incidence
VTE incidence in advanced lung cancer.
Measured: 12 months
VTE and overall survival
The influence on overall survival by VTE.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2018
- Study startJul 2018 (estimated)
- Primary completionJun 2021 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Lung NeoplasmsStudies of the same condition, open and under way.
- More trials run by Guangdong Provincial People's HospitalThe 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
- 1,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ZHEN WANG, Principal investigator, Guangdong General Hospital, Guangdong Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03581708
- Sponsor's protocol ID
- No.GDREC 2018009H
- Acronym
- RIVAL
- Status last verified
- May 2018
- First submitted
- 25 May 2018
- Last updated
- 10 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Khorana AA, Kuderer NM, Culakova E, Lyman GH, Francis CW. Development and validation of a predictive model for chemotherapy-associated thrombosis. Blood. 2008 May 15;111(10):4902-7. doi: 10.1182/blood-2007-10-116327. Epub 2008 Jan 23.
PubMed 18216292Blom JW, Doggen CJ, Osanto S, Rosendaal FR. Malignancies, prothrombotic mutations, and the risk of venous thrombosis. JAMA. 2005 Feb 9;293(6):715-22. doi: 10.1001/jama.293.6.715.
PubMed 15701913Tesselaar ME, Osanto S. Risk of venous thromboembolism in lung cancer. Curr Opin Pulm Med. 2007 Sep;13(5):362-7. doi: 10.1097/MCP.0b013e328209413c.
PubMed 17940477Levitan N, Dowlati A, Remick SC, Tahsildar HI, Sivinski LD, Beyth R, Rimm AA. Rates of initial and recurrent thromboembolic disease among patients with malignancy versus those without malignancy. Risk analysis using Medicare claims data. Medicine (Baltimore). 1999 Sep;78(5):285-91. doi: 10.1097/00005792-199909000-00001.
PubMed 10499070Thodiyil PA, Kakkar AK. Variation in relative risk of venous thromboembolism in different cancers. Thromb Haemost. 2002 Jun;87(6):1076-7. No abstract available.
PubMed 12083490Stein PD, Beemath A, Meyers FA, Skaf E, Sanchez J, Olson RE. Incidence of venous thromboembolism in patients hospitalized with cancer. Am J Med. 2006 Jan;119(1):60-8. doi: 10.1016/j.amjmed.2005.06.058.
PubMed 16431186Chew HK, Davies AM, Wun T, Harvey D, Zhou H, White RH. The incidence of venous thromboembolism among patients with primary lung cancer. J Thromb Haemost. 2008 Apr;6(4):601-8. doi: 10.1111/j.1538-7836.2008.02908.x. Epub 2008 Jan 17.
PubMed 18208538Wang Z, Yan HH, Yang JJ, Wang BC, Chen HJ, Zhou Q, Xu CR, Jiang BY, Wu YL. Venous thromboembolism risk factors in Chinese non-small cell lung cancer patients. Support Care Cancer. 2015 Mar;23(3):635-41. doi: 10.1007/s00520-014-2405-y. Epub 2014 Aug 27.
PubMed 25155313
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Study of the Incidence and Risk Factors of Venous Thromboembolism (VTE) in Chinese Advanced Stage Lung Cancer
- ClinicalTrials.gov ID
- NCT03581708
- Acronym / sponsor ID
- RIVAL / No.GDREC 2018009H
- Conditions
- Lung Neoplasms, Venous Thromboembolism
- Keywords
- lung cancer, Venous Thromboembolism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,400 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- Jul 2018 (estimated)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 10 Jul 2018 (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 is a prospective observatory clinical study, aiming to establish and validate venous thromboembolism risk model in Chinese advanced non-small cell lung cancer.
Detailed description
VTE has high incidence in lung cancer and increases the mortality. Appropriate preventive measures contribute to 50% increase of incidence. The investigators are to investigate the VTE in advanced non-small cell lung cancer and delineate the risk factors to establish a VTE risk model system helping clinicians to differentiate VTE high risk population and apply early prevention in order to reduce the incidence of VTE.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| advanced lung cancer | – | Other: lung cancerPatients diagnosed with advanced lung cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with advanced staged lung cancer with written informed consent.
Key inclusion criteria (6 listed)
- Age ≥ 18 years at the time of screening.
- Eastern Cooperative Oncology Group performance status of ≤ 2.
- Written informed consent obtained from the patient.
- Histologically and cytologically documented Stage 3B-4 lung cancer (according to Version 8 of the International Association for the Study of Lung Cancer Staging system).
- Patients with stage 1 to 3, who undergo radical therapy with disease free survival (DFS) >12 months.
Key exclusion criteria (4 listed)
- History of another primary malignancy except for malignancy treated with curative intent with known active disease ≥ 5 years before date of the informed consent.
- Without signed informed consent.
- Unwillingness or inability to comply with scheduled visits or other study procedures.
- Previously diagnosed with VTE before signing informed consent.
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 |
|---|---|---|
| lung cancerAlso: advance lung cancerIf the patient is diagnosed with lung cancer in advanced stage, he/she will be followed up for VTE incidence | Other | advanced lung cancer |
Primary outcome
VTE incidence risk evaluation
Time frame: 12 months
Real world VTE incidence risk evaluation in advanced lung cancer. Establish and validate VTE risk predictive model in Chinese advanced lung cancer.
2 secondary outcomes
VTE incidence
Time frame: 12 months
VTE and overall survival
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2018.
- Background: PubMed 18216292Khorana AA, Kuderer NM, Culakova E, Lyman GH, Francis CW. Development and validation of a predictive model for chemotherapy-associated thrombosis. Blood. 2008 May 15;111(10):4902-7. doi: 10.1182/blood-2007-10-116327. Epub 2008 Jan 23.
- Results publication: PubMed 15701913Blom JW, Doggen CJ, Osanto S, Rosendaal FR. Malignancies, prothrombotic mutations, and the risk of venous thrombosis. JAMA. 2005 Feb 9;293(6):715-22. doi: 10.1001/jama.293.6.715.
- Results publication: PubMed 17940477Tesselaar ME, Osanto S. Risk of venous thromboembolism in lung cancer. Curr Opin Pulm Med. 2007 Sep;13(5):362-7. doi: 10.1097/MCP.0b013e328209413c.
- Results publication: PubMed 10499070Levitan N, Dowlati A, Remick SC, Tahsildar HI, Sivinski LD, Beyth R, Rimm AA. Rates of initial and recurrent thromboembolic disease among patients with malignancy versus those without malignancy. Risk analysis using Medicare claims data. Medicine (Baltimore). 1999 Sep;78(5):285-91. doi: 10.1097/00005792-199909000-00001.
- Results publication: PubMed 12083490Thodiyil PA, Kakkar AK. Variation in relative risk of venous thromboembolism in different cancers. Thromb Haemost. 2002 Jun;87(6):1076-7. No abstract available.
- Results publication: PubMed 16431186Stein PD, Beemath A, Meyers FA, Skaf E, Sanchez J, Olson RE. Incidence of venous thromboembolism in patients hospitalized with cancer. Am J Med. 2006 Jan;119(1):60-8. doi: 10.1016/j.amjmed.2005.06.058.
- Results publication: PubMed 18208538Chew HK, Davies AM, Wun T, Harvey D, Zhou H, White RH. The incidence of venous thromboembolism among patients with primary lung cancer. J Thromb Haemost. 2008 Apr;6(4):601-8. doi: 10.1111/j.1538-7836.2008.02908.x. Epub 2008 Jan 17.
- Results publication: PubMed 25155313Wang Z, Yan HH, Yang JJ, Wang BC, Chen HJ, Zhou Q, Xu CR, Jiang BY, Wu YL. Venous thromboembolism risk factors in Chinese non-small cell lung cancer patients. Support Care Cancer. 2015 Mar;23(3):635-41. doi: 10.1007/s00520-014-2405-y. Epub 2014 Aug 27.
- Individual participant dataSharing planned: No
Related trials for Lung Neoplasms
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
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.
ZHEN WANG 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 Lung Neoplasms and Venous Thromboembolism, run by Guangdong Provincial People's Hospital 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 6 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: status not confirmed, as of the sponsor's last update on 10 Jul 2018. 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 ZHEN WANG, PhD (862083827812 ext. 50811, hunterol@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VTE incidence risk evaluation (time frame: 12 months). 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 NCT03581708, which also lists 8 linked publications.
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 10 Jul 2018.