Detection of Tumor DNA in Blood Samples From Cancer Patients

Study Overview
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Brief Summary
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The aim of this study is to employ genomic detection methodologies to measure the relative amount of tumor nucleic acids in the blood of a cancer patient with diagnosed metastatic disease that is either commencing, currently undergoing or completed cytotoxic chemotherapy treatment. More generally, this approach will allow us to develop a quantitative measure of therapy efficacy via the counting of the relative changes in tumor molecules over the course of treatment.

Official Title
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Detection of Tumor DNA in Blood Samples From Patients With Late Stage Cancer and Healthy Controls

Conditions
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Cancer, Tumors

Intervention / Treatment
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* Diagnostic Test: Blood test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years or older Have metastatic disease with from a solid tumor (e.g. breast, lung, colon, pancreas, ovary, prostate...) or stage II or III solid tumors undergoing curative surgery or neoadjuvant therapy followed by surgery Starting treatment or a new line of treatment Able to understand and grant informed consent Able to have their blood drawn Exclusion Criteria: Unable to grant informed consent or comply with all study procedures. Has a hematological malignancy, i.e. myeloma, lymphoma, MDS, leukemia

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Stage II or III curative surgery (closed to accrual)<br>Patients with stage II or III solid tumors undergoing curative intend surgery enrolled before surgery. | Diagnostic Test: Blood test<br>* No intervention except to collect blood for diagnostic test development<br>|
| Stage II or III neoadjuvant therapy cohort (closed to accrual)<br>Patients with stage II or III solid tumors undergoing neoadjuvant therapy followed by curative intend surgery enrolled before neoadjuvant therapy. | Diagnostic Test: Blood test<br>* No intervention except to collect blood for diagnostic test development<br>|
| Metastatic disease<br>Patients with advanced, recurrent and/or metastatic disease requiring systemic therapy with chemotherapy, targeted therapy, immunotherapy or a combination of any before initiation of any therapy or a new line of therapy following documentation of disease progression on prior therapy. | Diagnostic Test: Blood test<br>* No intervention except to collect blood for diagnostic test development<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between the tumor load score and patient response to therapies. | Determination of a direct correlation between the tumor load score and patient response to therapies. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of particular mutation events which underlie the basis of any established correlation with therapy response. | To determine which particular mutation events underlie the basis of any established correlation with therapy response. | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DNA in Tumors, cfDNA, WGS, Advanced stage cancer, Solid tumors