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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-30

Study Completion Date

2021-12-31

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.

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Detailed Description

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Conditions

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Neoplasms, Unknown Primary Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cancer of Unknown Primary (CUP)

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.

Circulating tumor cell and circulating tumor DNA test

Intervention Type GENETIC

Patient stratification based on presence or absence of suspicious findings of cells and DNA

Suspected CANcer (SCAN)

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.

Circulating tumor cell and circulating tumor DNA test

Intervention Type GENETIC

Patient stratification based on presence or absence of suspicious findings of cells and DNA

Interventions

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Circulating tumor cell and circulating tumor DNA test

Patient stratification based on presence or absence of suspicious findings of cells and DNA

Intervention Type GENETIC

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.