Lung CancerNCT01963533
The Roles of Age, Comorbidity, and Telomere Length in Lung Cancer Treatment and Prognosis
An observational study of Lung Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The investigators hypothesize that the age-adjusted telomere length in lung cancer patients before chemotherapy may be correlated to comorbidity status and predict outcome. The change of telomere length shortening after chemotherapy may relate to treatment side effect and treatment response. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Lung Cancer
- How many people
- 300 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2012to Dec 2015
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are newly diagnosed as lung cancer and prepared for scheduled chemotherapy in National Taiwan University Hospital will be enrolled for screening. The diagnosis is based on pathology via surgical specimen, or biopsy; or cytology via lung, lymph node aspiration or effusion study.
Who may be able to join
- Patients who are newly diagnosed as lung cancer and prepared for scheduled chemotherapy.
- The diagnosis is based on pathology via surgical specimen, or biopsy; or cytology via lung, lymph node aspiration or effusion study.
Who cannot join
- includes clinical diagnosis of lung cancer without pathology or cytology proving, combined with other type malignancy, and expected short survival time less than one month.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, Taiwan, 100
Kuan-Yu Chen, PHD, 886-972651046, tuff.chen@msa.hinet.net
Chien-Tai Hsu, 886-223123456 ext. 67779, chiyohsu@yahoo.com.tw
About this study
The investigators hypothesize that the age-adjusted telomere length in lung cancer patients before chemotherapy may be correlated to comorbidity status and predict outcome. The change of telomere length shortening after chemotherapy may relate to treatment side effect and treatment response.
Read the detailed description
Except chemotherapy, telomere shortening were also related to a variety of cellular stress, including hydrogen peroxide, UV, and x-irradiation, transforming growth factor-beta, overexpression of oncogenes such as Ha-Ras. The cellular stress induced telomere shortening and/or telomere dysfunction and promote accelerated senescence in normal and malignant cells. Oxidative stress, which presented in several chronic inflammatory diseases, such as atherosclerosis, coronary artery disease, and chronic obstructive airway disease, was also found to be correlated with telomere shortening.
- Conditions
- Lung Cancer
- Keywords
- lung cancer, telomere length, comorbidity, Eastern Cooperation Oncology Group (ECOG), chemotherapy
- Medical subject headings
- Lung Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
The correlation between telomere length shortening and cancer treatment outcome
The clinical data, including age, gender, clinical presentation, performance status, disease stage at diagnosis, initial treatment modality, progression-free survival of initial treatment, and survival duration will be recorded. Blood sample collection, quality of life, and cognitive function assessment will be performed before chemotherapy, one and four weeks after initial chemotherapy for telomere length measurement. Telomere length is measured by quantitative polymerase chain reaction(qPCR). Patients' characteristics are compared with chi-square test. Progression-free survival and survival time are analyzed by Kaplan-Meier with log rank test.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2013 (estimated)
- Study startAug 2012
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by National Taiwan University 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kuan-Yu Chen, PhD, Principal investigator, NTUH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01963533
- Sponsor's protocol ID
- 201207006RIC
- Status last verified
- Oct 2013
- First submitted
- 8 Oct 2013
- Last updated
- 18 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Roles of Age, Comorbidity, and Telomere Length in Lung Cancer Treatment and Prognosis
- ClinicalTrials.gov ID
- NCT01963533
- Acronym / sponsor ID
- 201207006RIC
- Conditions
- Lung Cancer
- Keywords
- lung cancer, telomere length, comorbidity, Eastern Cooperation Oncology Group (ECOG), chemotherapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 16 Oct 2013 (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.
The investigators hypothesize that the age-adjusted telomere length in lung cancer patients before chemotherapy may be correlated to comorbidity status and predict outcome. The change of telomere length shortening after chemotherapy may relate to treatment side effect and treatment response.
Detailed description
Except chemotherapy, telomere shortening were also related to a variety of cellular stress, including hydrogen peroxide, UV, and x-irradiation, transforming growth factor-beta, overexpression of oncogenes such as Ha-Ras. The cellular stress induced telomere shortening and/or telomere dysfunction and promote accelerated senescence in normal and malignant cells. Oxidative stress, which presented in several chronic inflammatory diseases, such as atherosclerosis, coronary artery disease, and chronic obstructive airway disease, was also found to be correlated with telomere shortening.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are newly diagnosed as lung cancer and prepared for scheduled chemotherapy in National Taiwan University Hospital will be enrolled for screening. The diagnosis is based on pathology via surgical specimen, or biopsy; or cytology via lung, lymph node aspiration or effusion study.
Key inclusion criteria (2 listed)
- Patients who are newly diagnosed as lung cancer and prepared for scheduled chemotherapy.
- The diagnosis is based on pathology via surgical specimen, or biopsy; or cytology via lung, lymph node aspiration or effusion study.
Key exclusion criteria (1 listed)
- includes clinical diagnosis of lung cancer without pathology or cytology proving, combined with other type malignancy, and expected short survival time less than one month.
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
The correlation between telomere length shortening and cancer treatment outcome
Time frame: 5 years
The clinical data, including age, gender, clinical presentation, performance status, disease stage at diagnosis, initial treatment modality, progression-free survival of initial treatment, and survival duration will be recorded. Blood sample collection, quality of life, and cognitive function assessment will be performed before chemotherapy, one and four weeks after initial chemotherapy for telomere length measurement. Telomere length is measured by quantitative polymerase chain reaction(qPCR). Patients' characteristics are compared with chi-square test. Progression-free survival and survival time are analyzed by Kaplan-Meier with log rank test.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2013.
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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.
Kuan-Yu Chen, PhD principal investigator
NTUH
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 National Taiwan University Hospital at 1 site in Taiwan.
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 2 inclusion and 1 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 18 Oct 2013. 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 Taiwan. 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 Chia-Lin Hsu (886-972651890, clhsu7@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The correlation between telomere length shortening and cancer treatment outcome (time frame: 5 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 18 Oct 2013.