Non Small Cell Lung CarcinomaNCT00759382
Prognostic Role of Primary Non Small Cell Lung Carcinoma Standardized F18-FDG Uptake Values (SUV and TLG) Measured With F18-fluorodeoxyglucose Positron Emission Tomography (F18-FDG-PET): a Non Interventional Study.
An observational study of Non Small Cell Lung Carcinoma, run by European Lung Cancer Working Party at 6 sites in Belgium.
Trial summary
The primary aim of this non interventional study is to assess the independent prognostic role on overall survival of primary tumour 18F-FDG uptake value (SUVmax) measured on 18fluorodeoxyglucose positron emission tomography (18F-FDG-PET) in patients with non-metastatic non-small cell lung cancers treated with curative… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Carcinoma
- How many people
- 340 participants
- Where
- 6 sitesBelgium
- Study dates
- Jul 2008to Jan 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: All patients presenting with non metastatic non small cell lung carcinoma, treated in the participating centres with curative intent
Who may be able to join
- Pathologically demonstrated NSCLC
- Stage I-III treated by curative treatment by surgery with or without chemotherapy (induction or adjuvant) or by chemoradiotherapy
- Inoperable patients treated by exclusive radiotherapy
- A whole-body (skull base to mid thighs) FDG-PET or a combined FDG-PET/CT on a dedicated machine, performed before any anticancer treatment
- FDG-PET or combined FDG-PET/CT has to be previously standardised according to the procedure described in appendix IV
- Written informed consent
- Accessibility to follow-up
- Age > 18 years
Who cannot join
- Prior anticancer treatment (surgery, radiotherapy or chemotherapy)
- Stage IV NSCLC
- A history of prior malignant tumour, except non-melanoma skin cancer or in situ carcinoma of the cervix and cured malignant tumour (more than 5-year disease free interval)
- Uncontrolled diabetes mellitus (fast glycaemia above 130 mg/dl)
- Pregnancy and lactating woman
- Unavailability to send a copy of the PET or PET-CT (DICOM format) to the data centre
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Belgium6 sites
Department of Pneumology RHMS Hôpital de la Madeleine
Ath, 7800
Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet
Brussels, 1000
Department of Pneumology CHU Charleroi
Charleroi, 6000
Department of Pneumology Hôpital Saint-Joseph
Gilly, 6060
Hôpital Ambroise Paré
Mons, 7000
Department of Pneumology Centre Hospitalier de Mouscron
Mouscron, 7700
About this study
The primary aim of this non interventional study is to assess the independent prognostic role on overall survival of primary tumour 18F-FDG uptake value (SUVmax) measured on 18fluorodeoxyglucose positron emission tomography (18F-FDG-PET) in patients with non-metastatic non-small cell lung cancers treated with curative intent, taking into account the other conventional prognostic factors (performance status, age, sex, disease stage).
- Conditions
- Non Small Cell Lung Carcinoma
- Keywords
- Non small cell lung carcinoma, PET scan, Observational study, Non metastatic, treated, curative intent
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| I | Patients with non-small cell lung carcinoma treated with curative intent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Measured: Survival will be dated from the date of PET scan
Secondary outcomes (1)
Progression-free survival
Measured: Period between the date of PET scan and the date of first progression or death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2008 (estimated)
- Study startJul 2008
- Primary completionJan 2021
- Study completionJan 2022 (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 CarcinomaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 340 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Lung Cancer Working Party
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thierry Berghmans, MD, Study chair, European Lung Cancer Working Party
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00759382
- Sponsor's protocol ID
- 01071
- Status last verified
- Aug 2021
- First submitted
- 24 Sep 2008
- Last updated
- 23 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Role of Primary Non Small Cell Lung Carcinoma Standardized F18-FDG Uptake Values (SUV and TLG) Measured With F18-fluorodeoxyglucose Positron Emission Tomography (F18-FDG-PET): a Non Interventional Study.
- ClinicalTrials.gov ID
- NCT00759382
- Acronym / sponsor ID
- 01071
- Conditions
- Non Small Cell Lung Carcinoma
- Keywords
- Non small cell lung carcinoma, PET scan, Observational study, Non metastatic, treated, curative intent
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 340 participants (estimated)
- Lead sponsor
- European Lung Cancer Working PartyUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Jan 2021 (actual)
- Study completion
- Jan 2022 (estimated)
- First posted
- 25 Sep 2008 (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 primary aim of this non interventional study is to assess the independent prognostic role on overall survival of primary tumour 18F-FDG uptake value (SUVmax) measured on 18fluorodeoxyglucose positron emission tomography (18F-FDG-PET) in patients with non-metastatic non-small cell lung cancers treated with curative intent, taking into account the other conventional prognostic factors (performance status, age, sex, disease stage).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| I | – | –Patients with non-small cell lung carcinoma treated with curative intent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients presenting with non metastatic non small cell lung carcinoma, treated in the participating centres with curative intent
Key inclusion criteria (8 listed)
- Pathologically demonstrated NSCLC
- Stage I-III treated by curative treatment by surgery with or without chemotherapy (induction or adjuvant) or by chemoradiotherapy
- Inoperable patients treated by exclusive radiotherapy
- A whole-body (skull base to mid thighs) FDG-PET or a combined FDG-PET/CT on a dedicated machine, performed before any anticancer treatment
- FDG-PET or combined FDG-PET/CT has to be previously standardised according to the procedure described in appendix IV
Key exclusion criteria (6 listed)
- Prior anticancer treatment (surgery, radiotherapy or chemotherapy)
- Stage IV NSCLC
- A history of prior malignant tumour, except non-melanoma skin cancer or in situ carcinoma of the cervix and cured malignant tumour (more than 5-year disease free interval)
- Uncontrolled diabetes mellitus (fast glycaemia above 130 mg/dl)
- Pregnancy and lactating woman
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
Survival
Time frame: Survival will be dated from the date of PET scan
1 secondary outcome
Progression-free survival
Time frame: Period between the date of PET scan and the date of first progression or death
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2021.
- Click here for more information on the protocolLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Non Small Cell Lung Carcinoma
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
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
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, 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.
Thierry Berghmans, MD study chair
European Lung Cancer Working Party
6 sites 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 Carcinoma, run by European Lung Cancer Working Party at 6 sites in Belgium.
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 6 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 23 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Belgium. 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?
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?
Survival (time frame: Survival will be dated from the date of PET scan). 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 23 Aug 2021.