Clinical Utility of Circulating Tumor DNA in Gastro-Esophageal Cancer

NCT ID: NCT04576858

Last Updated: 2020-10-06

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

1950 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-03

Study Completion Date

2025-07-31

Brief Summary

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This is a prospective cohort study designed to evaluate the treatment effect as well as predictive and prognostic factors with special emphasis on the clinical utility of ctDNA in plasma in patients with gastroesophageal cancer. Patients with gastroesophageal cancer are included in 5 separate cohorts scheduled for

* Surgical resection + perioperative chemotherapy (cohort 1)
* Neoadjuvant chemoradiotherapy followed by surgical resection (cohort 2)
* Definitive chemoradiotherapy with curative intent (cohort 3)
* Systemic therapy with the intent to prolong survival (cohort 4)
* Palliative treatment without the use of chemotherapy (cohort 5)

Detailed Description

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Conditions

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Esophageal Cancer Gastric Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort 1: Surgical resection + perioperative chemotherapy

Circulating tumor DNA

Intervention Type DIAGNOSTIC_TEST

Measurement of circulating tumor DNA from plasma over a period of 2 years.

Cohort 2: Neoadjuvant chemoradiotherapy followed by surgery

Circulating tumor DNA

Intervention Type DIAGNOSTIC_TEST

Measurement of circulating tumor DNA from plasma over a period of 2 years.

Cohort 3: Definitive chemoradiotherapy

Circulating tumor DNA

Intervention Type DIAGNOSTIC_TEST

Measurement of circulating tumor DNA from plasma over a period of 2 years.

Cohort 4: Chemotherapy with the aim to prolong life expectancy

Circulating tumor DNA

Intervention Type DIAGNOSTIC_TEST

Measurement of circulating tumor DNA from plasma over a period of 2 years.

Cohort 5: Non-chemotherapeutic palliation

E.g. Palliative radiotherapy

No interventions assigned to this group

Interventions

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Circulating tumor DNA

Measurement of circulating tumor DNA from plasma over a period of 2 years.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

Gastroesophageal cancer Age 18 years or older Able to understand and sign written informed consent

Exclusion Criteria

Patients not providing informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Morten Mau-Sørensen

Chief Physician, MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Rigshospitalet

Copenhagen, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Morten Mau-Sørensen, MD, PhD

Role: CONTACT

35450879 ext. 0045

Facility Contacts

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Morten Mau-Sørensen, MD, PhD

Role: primary

35450879 ext. 0045

Other Identifiers

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CURE

Identifier Type: -

Identifier Source: org_study_id

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