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New treatment option for Gastrointestinal Neoplasm
Official title The ctDNA-RECIST Trial Part One
ClinicalTrials.gov ID: NCT06562348
What this study is testing
- What it's testing
- A study investigating if analysis of circulating tumor DNA (ctDNA) can guide palliative treatment in patients with gastrointestinal cancer.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Incurable metastatic gastrointestinal cancer
- Indication for first or second-line systemic treatment
- Measurable disease according to RECIST v.1.1
- CT of chest and abdomen less than 30 days old at time of treatment initiation
- Age at least 18 years
You likely can't join if
- Incapacity, frailty, disability and comorbidity to a degree that according to the investigator is not compatible with combination chemotherapy
- Other concurrent malignant tumor except non-melanoma skin cancer or carcinoma in situ cervicis uteri
- Pregnant (positive pregnancy test) or breast-feeding women
See the full eligibility criteria
- Incurable metastatic gastrointestinal cancer
- Indication for first or second-line systemic treatment
- Measurable disease according to RECIST v.1.1
- CT of chest and abdomen less than 30 days old at time of treatment initiation
- Age at least 18 years
- ECOG performance status 0-2
- Clinically eligible systemic palliative treatment at investigators decision.
- Adequate bone marrow, liver and renal function allowing systemic chemotherapy
- Anticonception for fertile women and for male patients with a fertile partner. Intrauterine device, vasectomy of a female subject's male partner or hormonal contraceptive are acceptable
- Written and verbally informed consent
- Incapacity, frailty, disability and comorbidity to a degree that according to the investigator is not compatible with combination chemotherapy
- Other concurrent malignant tumor except non-melanoma skin cancer or carcinoma in situ cervicis uteri
- Pregnant (positive pregnancy test) or breast-feeding women
The study team makes the final eligibility decision.
Where it's taking place
- Aarhus, Denmark
- Vejle, Denmark
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aarhus, Denmark; Vejle, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.