TRAcking Non-small Cell Lung Cancer Evolution Through Therapy (Rx) (TRACERx)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01888601|
Recruitment Status : Active, not recruiting
First Posted : June 28, 2013
Last Update Posted : February 10, 2023
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease|
|Non-small Cell Lung Cancer|
|Study Type :||Observational|
|Actual Enrollment :||814 participants|
|Official Title:||TRAcking Non-small Cell Lung Cancer Evolution Through Therapy (Rx)|
|Study Start Date :||April 2014|
|Estimated Primary Completion Date :||December 2026|
|Estimated Study Completion Date :||December 2026|
NSCLC eligible for primary surgery
NSCLC eligible for primary surgery
- Intratumour heterogeneity [ Time Frame: Year 5 ]• Define the relationship between intratumour heterogeneity and clinical outcome following surgery and adjuvant therapy (including relationships between intratumour heterogeneity and clinical disease stage and histological subtypes of NSCLC).
Biospecimen Retention: Samples With DNA
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- Written Informed consent
- Patients ≥18 years of age, with early stage IIA-IIIB disease (according to TNM 8th edition) who are eligible for primary surgery. Patients with a radiological staging of IB (N0) who could be upstaged to IIA-IIIB following surgery (due to the presence of possible nodal involvement on the pre-operative scan) may also be included, but will be withdrawn if post-surgical staging remains IB.
Histopathologically confirmed NSCLC, or a strong suspicion of cancer on lung imaging necessitating surgery (e.g. diagnosis determined from frozen section in theatre)
- Primary surgery in keeping with NICE guidelines planned (see section 9.3)
- Agreement to be followed up at a TRACERx site
- Performance status 0 or 1
- Minimum tumour diameter at least 15mm to allow for sampling of at least two tumour regions (if 15mm, a high likelihood of nodal involvement on pre-operative imaging required to meet eligibility according to stage, i.e. T1N1-3)
- Any other* malignancy diagnosed or relapsed at any time, which is currently being treated (including by hormonal therapy).
Any other* current malignancy or malignancy diagnosed or relapsed within the past 3 years**.
*Exceptions are: non-melanomatous skin cancer, stage 0 melanoma in situ, and in situ cervical cancer
**An exception will be made for malignancies diagnosed or relapsed more than 2, but less than 3, years ago only if a pre-operative biopsy of the lung lesion has confirmed a diagnosis of NSCLC.
- Psychological condition that would preclude informed consent
- Treatment with neo-adjuvant therapy for current lung malignancy deemed necessary
- Post-surgery staging is not IIA-IIIB
- Known Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) or syphilis infection.
- Sufficient tissue, i.e. a minimum of two tumour regions, is unlikely to be obtained for the study based on pre-operative imaging
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01888601
|Principal Investigator:||Charles Swanton||Chief Investigator|
|Responsible Party:||University College, London|
|Other Study ID Numbers:||
|First Posted:||June 28, 2013 Key Record Dates|
|Last Update Posted:||February 10, 2023|
|Last Verified:||February 2023|
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Neoplasms by Site
Respiratory Tract Diseases