Lung CancerNCT00213733
Molecular Assessment of Lymph Nodes in Patients With Resected (Stage I to IIIA) Non-small Cell Lung Cancer
An observational study of Lung Cancer, run by University Hospital, Strasbourg, France at 5 sites in France.
Trial summary
This is a prospective study of surgically resected samples and lymph nodes of lung cancer patients. For histopathologically positive lymph nodes from a complete resection, the investigators would like to analyse tumor tissue by allelotyping and comparing these results with those observed in the primary lung tumor to… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lung Cancer
- How many people
- 150 participants
- Where
- 5 sitesFrance
- Study dates
- Jun 2004to Aug 2011
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with resectable non-small cell lung cancer (stage I to IIIA), with a complete resection of the tumor and paired lymph nodes
Who may be able to join
- Patients with resectable non-small cell lung cancer (stage I to IIIA), with a complete resection of the tumor and paired lymph nodes.
- Informed consent is required.
Who cannot join
- Another cancer
- Chemotherapy before surgical treatment
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Service de Chirurgie Thoracique, Hôpital Civil
Strasbourg, 67091
Service de Pneumologie, Hôpital Lyautey
Strasbourg, 67091
Laboratoire de Biochimie et de Biologie Moléculaire, Hôpital de Hautepierre
Strasbourg, 67098
Service d'Anatomie Pathologique, Hôpital de Hautepierre
Strasbourg, 67098
Service de Pneumologie, Hôpital de Hautepierre
Strasbourg, 67098
About this study
Official title: Research of Molecular Markers for Diagnosis and/or Prognosis in Lymph Node Metastasis of Resected Non-small Cell Lung Cancer
This is a prospective study of surgically resected samples and lymph nodes of lung cancer patients. For histopathologically positive lymph nodes from a complete resection, the investigators would like to analyse tumor tissue by allelotyping and comparing these results with those observed in the primary lung tumor to establish a cartography of molecular alteration in resected lung cancer. For non histopathologically positive lymph nodes, the investigators would like to research the presence (or not) of micrometastasis by allele-specific PCR (polymerase chain reaction).
Read the detailed description
Genetic: It is a prospective study during two years with three years for follow-up. No control group is recruited.
- Conditions
- Lung Cancer
- Keywords
- Lung cancer patients, non-small cell lung cancer, molecular marker, lymph node completed resected, Lung cancer samples and paired lymph node resected
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startJun 2004
- Study completionAug 2011
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 University Hospital, Strasbourg, FranceThe 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Investigators
- Michèle BEAU-FALLER, MD, Principal investigator, Laboratoire de Biochimie et de Biologie Moléculaire, Hôpital de Hautepierre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00213733
- Sponsor's protocol ID
- 3207
- Status last verified
- Aug 2011
- First submitted
- 13 Sep 2005
- Last updated
- 30 Aug 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research of Molecular Markers for Diagnosis and/or Prognosis in Lymph Node Metastasis of Resected Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00213733
- Acronym / sponsor ID
- 3207
- Conditions
- Lung Cancer
- Keywords
- Lung cancer patients, non-small cell lung cancer, molecular marker, lymph node completed resected, Lung cancer samples and paired lymph node resected
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Jun 2004
- Study completion
- Aug 2011 (actual)
- First posted
- 21 Sep 2005 (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.
This is a prospective study of surgically resected samples and lymph nodes of lung cancer patients. For histopathologically positive lymph nodes from a complete resection, the investigators would like to analyse tumor tissue by allelotyping and comparing these results with those observed in the primary lung tumor to establish a cartography of molecular alteration in resected lung cancer. For non histopathologically positive lymph nodes, the investigators would like to research the presence (or not) of micrometastasis by allele-specific PCR (polymerase chain reaction).
Detailed description
Genetic: It is a prospective study during two years with three years for follow-up. No control group is recruited.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with resectable non-small cell lung cancer (stage I to IIIA), with a complete resection of the tumor and paired lymph nodes
Key inclusion criteria (2 listed)
- Patients with resectable non-small cell lung cancer (stage I to IIIA), with a complete resection of the tumor and paired lymph nodes.
- Informed consent is required.
Key exclusion criteria (2 listed)
- Another cancer
- Chemotherapy before surgical treatment
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
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2011.
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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.
Michèle BEAU-FALLER, MD principal investigator
Laboratoire de Biochimie et de Biologie Moléculaire, Hôpital de Hautepierre
5 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 University Hospital, Strasbourg, France at 5 sites in France.
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 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: finished, as of the sponsor's last update on 30 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 30 Aug 2011.