Molecular Analysis of Blood Samples in Standardized Cancer Care Referrals for SCAN and CUP

Study Overview
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Brief Summary
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Patients with suspected cancer (SCAN) and cancer of unknown primary tumor (CUP) are vulnerable because the investigation is difficult and expensive and have poor prognosis because few effective established curative treatments are available. Great progress has been made, for example through highly qualified and systematic clinical investigations not least within the framework of the standardized care processes. However, there is a need for faster, less invasive and more cost-effective tests to confirm or exclude the diagnosis of carcinoma (epithelial cancer), primarily for SCAN and secondly for CUP, and partly to receive suggestions for localization of the primary tumor for primarily CUP and secondly SCAN. There is also a need for prediction of molecularly targeted therapies. New research provides opportunities for using a blood test to acquire detailed and updated information about the individual patient's disease and thus also open new opportunities for faster, less invasive and more cost-effective diagnosis and prediction of molecularly targeted treatments based on individualized sampling and molecular stratification. It is important that these opportunities are tested in a timely fashion in practical health care, so the new opportunities can be taken advantage of and developed in the best way. The aim is to establish a new best practice for these hard-to-study and difficult-to-treat patients. Samples will be taken of epithelial cells circulating in the blood, and of the free circulating DNA. As a reference, germ-line DNA will also be sampled, also from regular blood samples. The analyses will show whether the cellular and molecular tests can work in the existing standardized care processes for SCAN and CUP, or if adaptations in routines, training or equipment need to be introduced. The analyses will also give an indication of whether the cellular and molecular sample analyses provide practically useful information for confirming or refuting the diagnosis of cancer, suggesting from which organ the cancer originated and for predicting individualized therapies, and whether adaptations in routines, training or technology need to be introduced.

Official Title
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The Value of Molecular Biological Analysis of Blood Samples in Standardized Care Procedures in Suspected Cancer (SCAN) and Cancer of Unknown Primary (CUP)

Conditions
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Neoplasms, Unknown Primary, Cancer

Intervention / Treatment
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* Genetic: Circulating tumor cell and circulating tumor DNA test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 200 patients who were referred to be investigated and diagnosed at the Diagnostic Centre (DC) in Södertälje, Sweden, for suspected cancer (SCAN) with serious non-specific symptoms with signs of cancer, or with suspected cancer of unknown primary (CUP) and which give informed consent to participate in the study. Exclusion Criteria: All patients who have been referred and consented are included.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 125 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cancer of Unknown Primary (CUP)<br>Subjects referred, based on standardised criteria, for investigation and diagnosis for possible cancer of unknown primary (CUP). Blood samples to be investigated for presence of circulating tumor cells and circulating tumor DNA. | Genetic: Circulating tumor cell and circulating tumor DNA test<br>* Patient stratification based on presence or absence of suspicious findings of cells and DNA<br>|
| Suspected CANcer (SCAN)<br>Subjects referred, based on standardised criteria, for investigation and diagnosis for suspected cancer (SCAN) based on serious non-specific symptoms and signs of cancer. Blood samples to be investigated for presence of circulating tumor cells and circulating tumor DNA. | Genetic: Circulating tumor cell and circulating tumor DNA test<br>* Patient stratification based on presence or absence of suspicious findings of cells and DNA<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Possibility of cellular and genomic sampling as part of the standardised care process | Can blood samples be taken, processed in a timely manner and processed for isolation and analysis of circulating epithelial cells and free circulating DNA within the framework of the standardized care process for SCAN and CUP? | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cellular and genomic sample analyses | Are the cellular and molecular sample analyses already practically useful for the universal confirmation or exclusion of the diagnosis of epithelial cancer, suggest from which anatomic location the cancer originated and predict individualised treatment, or should the test be re-focused on certain areas of diagnosis, or developed technically, in order to assist the diagnostic investigation and predict the treatment based on detailed information of the current state of the individual patient's disease? | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Germ line DNA, gDNA, Circulating tumor cell, CTC, Circulating cell free DNA, cfDNA, ctDNA, Screening, Diagnostic, Predictive