Lung CancerNCT03286036
Clinical and Molecular Staging of Lung Cancer Stages I and IIp
An observational study of Lung Cancer, run by Corporacion Parc Tauli at 4 sites in Spain.
Trial summary
The classification of lung cancer (LC) according to the degree of anatomical extension (TNM) allows the estimation of the prognosis of the patient, although its accuracy is limited. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- biomarkers
- How many people
- 200 participants
- Where
- 4 sitesSpain
- Study dates
- 1 Jan 2013to 31 Dec 2020
- How long will I take part?
- 3 Years
- 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 to 80 years
- All sexes
- Adult, Older adult
Study population: Lung cancer patients who undergo surgical resection of their tumors in a Spanish hospital with thoracic surgery and pathological anatomy departments
Who may be able to join
- over 18 years old
- Able to understand and sign the informed consent
Who cannot join
- Absence of mediastinal disease
Trial locations and contacts
4 sites in 1 country.
Spain4 sites
Hospital Germans Trias i Pujol
Badalona, Barcelona, 08916
Hospital del Mar
Barcelona, 08003
Hospital Son Espases
Palma de Mallorca, Balearic Islands, 07010
Hospital Virgen del Rocio
Seville, 41013
About this study
Official title: Clinical and Molecular Staging of Lung Cancer Stages I and IIp: Generation and Initial Analysis of a Clinical and Molecular Knowledge Database
The classification of lung cancer (LC) according to the degree of anatomical extension (TNM) allows the estimation of the prognosis of the patient, although its accuracy is limited. In fact, one third of surgically-treated patients with initial disease have recurrences during follow-up, despite the negativity of node dissection at surgery. The incorporation of genetic, epigenetic and proteomic information to TNM staging will characterize more accurately the lung cancer, and thereby improve the prognostic and the prediction of the therapeutic response in these patients.In this project a prospective cohort of 320 patients with lung cancer staged I-IIp will be studied, combining the clinical and pathologic information available with genetic, epigenetic and proteomic markers in tumour samples, pulmonary tissue, regional nodes and peripheral blood, preserved in suitable systems for the application of complex analytical methodologies. Thus, a knowledge database will be created with the aim of improving the prognostic and prediction capabilities of TNM staging.This project is coordinated with related sub-projects that cover the required laboratory tests on biological samples and with Spanish collaborative group in lung cancer.
- Conditions
- Lung Cancer
- Being tested
- biomarkers
- Keywords
- Biomarkers, early detection
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biomarkersOther
This is an observational study, there is no intervention
| Study group | Role | What they receive |
|---|---|---|
| Lung cancer patients | Patients with lung cancer who undergo surgical resection of the tumor Receives: Other: biomarkers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cohort creation
Prospective cohort with detailed information of the clinical characteristics at the time of surgery and with biological samples
Measured: 6 years
Secondary outcomes (1)
Biological markers
To identify biological variables with potential prognostic and / or predictive capacity of the therapeutic response, independent of the pathological TNM, in biological samples
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2017
- Study start1 Jan 2013
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III, Consorcio Centro de Investigación Biomédica en Red (CIBER)
- Responsible party
- Principal investigator, Eduard Monsó-Molas, Corporacion Parc Tauli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03286036
- Sponsor's protocol ID
- PI12/02040
- Status last verified
- Feb 2019
- First submitted
- 14 Sep 2017
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: This is a multicenter study and the patients' samples and clinical data will be available to the study collaborators when the recruitment finishes.
Publications
Monso E, Montuenga LM, Sanchez de Cos J, Villena C; Lung Cancer CIBERES-RTICC-SEPAR-Plataforma Biobanco Pulmonar. Biological Marker Analysis as Part of the CIBERES-RTIC Cancer-SEPAR Strategic Project on Lung Cancer. Arch Bronconeumol. 2015 Sep;51(9):462-7. doi: 10.1016/j.arbres.2014.11.010. Epub 2015 Jan 19. English, Spanish.
PubMed 25614375
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Molecular Staging of Lung Cancer Stages I and IIp: Generation and Initial Analysis of a Clinical and Molecular Knowledge Database
- ClinicalTrials.gov ID
- NCT03286036
- Acronym / sponsor ID
- PI12/02040
- Conditions
- Lung Cancer
- Keywords
- Biomarkers, early detection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III, Consorcio Centro de Investigación Biomédica en Red (CIBER)
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 18 Sep 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.
The classification of lung cancer (LC) according to the degree of anatomical extension (TNM) allows the estimation of the prognosis of the patient, although its accuracy is limited. In fact, one third of surgically-treated patients with initial disease have recurrences during follow-up, despite the negativity of node dissection at surgery. The incorporation of genetic, epigenetic and proteomic information to TNM staging will characterize more accurately the lung cancer, and thereby improve the prognostic and the prediction of the therapeutic response in these patients.In this project a prospective cohort of 320 patients with lung cancer staged I-IIp will be studied, combining the clinical and pathologic information available with genetic, epigenetic and proteomic markers in tumour samples, pulmonary tissue, regional nodes and peripheral blood, preserved in suitable systems for the application of complex analytical methodologies. Thus, a knowledge database will be created with the aim of improving the prognostic and prediction capabilities of TNM staging.This project is coordinated with related sub-projects that cover the required laboratory tests on biological samples and with Spanish collaborative group in lung cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lung cancer patients | – | Other: biomarkersPatients with lung cancer who undergo surgical resection of the tumor |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Lung cancer patients who undergo surgical resection of their tumors in a Spanish hospital with thoracic surgery and pathological anatomy departments
Key inclusion criteria (2 listed)
- over 18 years old
- Able to understand and sign the informed consent
Key exclusion criteria (1 listed)
- Absence of mediastinal disease
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 |
|---|---|---|
| biomarkersThis is an observational study, there is no intervention | Other | Lung cancer patients |
Primary outcome
Cohort creation
Time frame: 6 years
Prospective cohort with detailed information of the clinical characteristics at the time of surgery and with biological samples
1 secondary outcome
Biological markers
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Background: PubMed 25614375Monso E, Montuenga LM, Sanchez de Cos J, Villena C; Lung Cancer CIBERES-RTICC-SEPAR-Plataforma Biobanco Pulmonar. Biological Marker Analysis as Part of the CIBERES-RTIC Cancer-SEPAR Strategic Project on Lung Cancer. Arch Bronconeumol. 2015 Sep;51(9):462-7. doi: 10.1016/j.arbres.2014.11.010. Epub 2015 Jan 19. English, Spanish.
- Individual participant dataSharing planned: Yes. This is a multicenter study and the patients' samples and clinical data will be available to the study collaborators when the recruitment finishes.
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites 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 Corporacion Parc Tauli at 4 sites in Spain.
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 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain. 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?
Cohort creation (time frame: 6 years). 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 NCT03286036, 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 15 Feb 2019.