Lung CancerNCT03384680
Symptom Collection of Lung Cancer Patients
An observational study of Lung Cancer, run by Seong-Gyu Ko at 1 site in South Korea.
Trial summary
This study is conducted to collect the symptoms of lung cancer patients and to observe the relationship with proteomics. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 16 Sep 2015to 31 May 2018
- 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 with lung cancer who are scheduled for surgery will be enrolled.
Who may be able to join
- Adult over 18 years old
- Patients are scheduled for surgery with lung cancer diagnosis.
- ECOG status score 0 to 2
- Individual who can read and understand Korean
- Participant is willing and able to give informed consent for participation in the study
Who cannot join
- Patient who was diagnosed with lung cancer in the past.
- Individuals who are judged inappropriate for the study
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Korea University Guro Hospital
Seoul
Hyjin Son
About this study
Official title: A Study on Symptom Collection of Patients With Lung Cancer.
This study is conducted to collect the symptoms of lung cancer patients and to observe the relationship with proteomics.
- Conditions
- Lung Cancer
- Medical subject headings
- Lung Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Pattern identification
Pattern identification by Body constitution questionnaire(BCQ) BCQ(+) is a questionnaire that is comprised of nineteen questions with one-to-five rating scales, making the range of total score to be between nineteen and ninety-five points with the cut-off score of 30.5 points for Yang-Xu.
BCQ(-) is composed of another set of nineteen questions with the same five-point Likert scales, with the cut-off score of 29.5 points for Yin-Xu.
BCQ(s) consists of twenty-three questions with the same Likert scale cut-off score of 26.5 points for Stasis.
Measured: For 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2017
- Study start16 Sep 2015
- Primary completion31 Mar 2018 (estimated)
- Study completion31 May 2018 (estimated)
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 Lung CancerStudies 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
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seong-Gyu Ko
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Seong-Gyu Ko, Kyunghee University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03384680
- Sponsor's protocol ID
- KCRD_Lung cancer_Symptoms
- Status last verified
- Jan 2018
- First submitted
- 20 Dec 2017
- Last updated
- 9 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cho W, Kim JH, Jeong M, Kim MS, Lee J, Son H, Cheon C, Park S, Ko SG. Pattern identification of lung cancer patients based on body constitution questionnaires (BCQ) and glycoproteomics for precision medicine. Medicine (Baltimore). 2019 Jun;98(24):e16035. doi: 10.1097/MD.0000000000016035.
PubMed 31192960
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on Symptom Collection of Patients With Lung Cancer.
- ClinicalTrials.gov ID
- NCT03384680
- Acronym / sponsor ID
- KCRD_Lung cancer_Symptoms
- Conditions
- Lung Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Seong-Gyu KoUniversity, hospital or other
- Study start
- 16 Sep 2015 (actual)
- Primary completion
- 31 Mar 2018 (estimated)
- Study completion
- 31 May 2018 (estimated)
- First posted
- 27 Dec 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.
This study is conducted to collect the symptoms of lung cancer patients and to observe the relationship with proteomics.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with lung cancer who are scheduled for surgery will be enrolled.
Key inclusion criteria (5 listed)
- Adult over 18 years old
- Patients are scheduled for surgery with lung cancer diagnosis.
- ECOG status score 0 to 2
- Individual who can read and understand Korean
- Participant is willing and able to give informed consent for participation in the study
Key exclusion criteria (2 listed)
- Patient who was diagnosed with lung cancer in the past.
- Individuals who are judged inappropriate for the study
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
Pattern identification
Time frame: For 1 year
Pattern identification by Body constitution questionnaire(BCQ) BCQ(+) is a questionnaire that is comprised of nineteen questions with one-to-five rating scales, making the range of total score to be between nineteen and ninety-five points with the cut-off score of 30.5 points for Yang-Xu. BCQ(-) is composed of another set of nineteen questions with the same five-point Likert scales, with the cut-off score of 29.5 points for Yin-Xu. BCQ(s) consists of twenty-three questions with the same Likert scale cut-off score of 26.5 points for Stasis.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2018.
- Derived from this study: PubMed 31192960Cho W, Kim JH, Jeong M, Kim MS, Lee J, Son H, Cheon C, Park S, Ko SG. Pattern identification of lung cancer patients based on body constitution questionnaires (BCQ) and glycoproteomics for precision medicine. Medicine (Baltimore). 2019 Jun;98(24):e16035. doi: 10.1097/MD.0000000000016035.
- Individual participant dataSharing planned: No
Related trials for Lung Cancer
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.
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 Cancer, run by Seong-Gyu Ko at 1 site in South Korea.
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 5 inclusion and 2 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 Jan 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 South Korea. 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 Chunhoo Cheon (02-961-9278, pm.thehoo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pattern identification (time frame: For 1 year). 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 NCT03384680, 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 9 Jan 2018.