Lung Cancer, Nonsmall CellNCT04634630
The Influence of Cancer Stem-cells on Risk of Relapse in Patients Harboring Adenocarcinoma and Squamous Cell Carcinoma of the Lung
An observational study of Lung Cancer, Nonsmall Cell and Relapse/Recurrence, run by Beatrice Aramini at 1 site in Italy.
Trial summary
The present study is a prospective cohort study. The aim is to assess the relationship between the presence of cancer stem-cells (CSC) and the risk of relapse in patients with early and locally advanced adenocarcinoma and squamous cell carcinoma of the lung Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Lung Cancer, Nonsmall Cell, Relapse/Recurrence, CSC
- What is being tested?
- Exposure to lung cancer stem cells
- How many people
- 35 participants
- Where
- 1 siteItaly
- Study dates
- 17 Oct 2017to 17 Oct 2020
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent major lung resection by lateral thoracotomy or videothoracoscopic approach for stage I, II, or IIIA adenocarcinoma or squamous cell carcinoma of the lung (tumor, node, metastasis (TNM) staging system, eighth edition)
Who may be able to join
- patients with stage I, II or IIIA adenocarcinoma of squamous cell carcinoma of the lung
- age between 18 and 85
- R0 resection
- availability of formalin-fixed, paraffin-embedded surgery specimen from the primary tumor
- availability of fresh surgical specimen for cytofluorimetric analysis
Who cannot join
- incomplete resection
- unknown tumor, node or metastasis status
- synchronous tumors
- previous lung cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of Cancer Stem-cells on Risk of Relapse in Patients Harboring Adenocarcinoma and Squamous Cell Carcinoma of the Lung: a Prospective Cohort Study
The present study is a prospective cohort study. The aim is to assess the relationship between the presence of cancer stem-cells (CSC) and the risk of relapse in patients with early and locally advanced adenocarcinoma and squamous cell carcinoma of the lung
- Conditions
- Lung Cancer, Nonsmall Cell, Relapse/Recurrence, CSC
- Being tested
- Exposure to lung cancer stem cells
- Keywords
- Non Small Cell Lung Cancer, Cancer Stem Cells
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure to lung cancer stem cellsGenetic
The exposure to lung cancer stem cells was measure as the percentage of Aldehyde dehydrogenase (ALDH) on all viable cells extracted from surgically resected tumor specimens
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse Free Survival
Days from lung cancer resection to relapse
Measured: Minimum follow-up time: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2020
- Study start17 Oct 2017
- Primary completion17 Oct 2020
- Study completion17 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lung Cancer, Nonsmall CellStudies 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
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beatrice Aramini
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Beatrice Aramini, Azienda Ospedaliero-Universitaria di Modena
- Investigators
- Uliano Morandi, MD, Principal investigator, Azienda Ospedaliero-Universitaria di Modena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04634630
- Sponsor's protocol ID
- STEMCELL/1
- Status last verified
- May 2021
- First submitted
- 12 Nov 2020
- Last updated
- 1 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Masciale V, Banchelli F, Grisendi G, D'Amico R, Maiorana A, Stefani A, Morandi U, Stella F, Dominici M, Aramini B. Cancer Stem Cells and Cell Cycle Genes as Independent Predictors of Relapse in Non-small Cell Lung Cancer: Secondary Analysis of a Prospective Study. Stem Cells Transl Med. 2022 Aug 23;11(8):797-804. doi: 10.1093/stcltm/szac040.
PubMed 35674389Masciale V, Banchelli F, Grisendi G, D'Amico R, Maiorana A, Stefani A, Morandi U, Stella F, Dominici M, Aramini B. The Influence of Cancer Stem Cells on the Risk of Relapse in Adenocarcinoma and Squamous Cell Carcinoma of the Lung: A Prospective Cohort Study. Stem Cells Transl Med. 2022 Mar 31;11(3):239-247. doi: 10.1093/stcltm/szab029.
PubMed 35356974
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Cancer Stem-cells on Risk of Relapse in Patients Harboring Adenocarcinoma and Squamous Cell Carcinoma of the Lung: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04634630
- Acronym / sponsor ID
- STEMCELL/1
- Conditions
- Lung Cancer, Nonsmall Cell, Relapse/Recurrence, CSC
- Keywords
- Non Small Cell Lung Cancer, Cancer Stem Cells
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Beatrice AraminiUniversity, hospital or other
- Study start
- 17 Oct 2017 (actual)
- Primary completion
- 17 Oct 2020 (actual)
- Study completion
- 17 Oct 2020 (actual)
- First posted
- 18 Nov 2020 (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 present study is a prospective cohort study. The aim is to assess the relationship between the presence of cancer stem-cells (CSC) and the risk of relapse in patients with early and locally advanced adenocarcinoma and squamous cell carcinoma of the lung
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent major lung resection by lateral thoracotomy or videothoracoscopic approach for stage I, II, or IIIA adenocarcinoma or squamous cell carcinoma of the lung (tumor, node, metastasis (TNM) staging system, eighth edition)
Key inclusion criteria (5 listed)
- patients with stage I, II or IIIA adenocarcinoma of squamous cell carcinoma of the lung
- age between 18 and 85
- R0 resection
- availability of formalin-fixed, paraffin-embedded surgery specimen from the primary tumor
- availability of fresh surgical specimen for cytofluorimetric analysis
Key exclusion criteria (4 listed)
- incomplete resection
- unknown tumor, node or metastasis status
- synchronous tumors
- previous lung cancer
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 |
|---|---|---|
| Exposure to lung cancer stem cellsThe exposure to lung cancer stem cells was measure as the percentage of Aldehyde dehydrogenase (ALDH) on all viable cells extracted from surgically resected tumor specimens | Genetic | – |
Primary outcome
Relapse Free Survival
Time frame: Minimum follow-up time: 1 year
Days from lung cancer resection to relapse
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 1 Jun 2021.
- Derived from this study: PubMed 35674389Masciale V, Banchelli F, Grisendi G, D'Amico R, Maiorana A, Stefani A, Morandi U, Stella F, Dominici M, Aramini B. Cancer Stem Cells and Cell Cycle Genes as Independent Predictors of Relapse in Non-small Cell Lung Cancer: Secondary Analysis of a Prospective Study. Stem Cells Transl Med. 2022 Aug 23;11(8):797-804. doi: 10.1093/stcltm/szac040.
- Derived from this study: PubMed 35356974Masciale V, Banchelli F, Grisendi G, D'Amico R, Maiorana A, Stefani A, Morandi U, Stella F, Dominici M, Aramini B. The Influence of Cancer Stem Cells on the Risk of Relapse in Adenocarcinoma and Squamous Cell Carcinoma of the Lung: A Prospective Cohort Study. Stem Cells Transl Med. 2022 Mar 31;11(3):239-247. doi: 10.1093/stcltm/szab029.
- Individual participant dataSharing planned: No
Related trials for Lung Cancer, Nonsmall Cell
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.
Uliano Morandi, MD principal investigator
Azienda Ospedaliero-Universitaria di Modena
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, Nonsmall Cell and Relapse/Recurrence, run by Beatrice Aramini at 1 site in Italy.
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 4 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 1 Jun 2021. 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 Italy. 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.
What does the primary outcome measure?
Relapse Free Survival (time frame: Minimum follow-up time: 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 NCT04634630, which also lists 2 linked publications.
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 1 Jun 2021.