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NCT Number: NCT06698146

Colorectal Metastasis to Liver Extraction With Auxiliary Transplant and Delayed Resection

Liver transplantation (LT) has become an accepted treatment for selected patients with unresectable liver metastases due to colorectal cancer (CRLM). The goal of this study is to look at and compare the clinical results of all the different approved methods (living vs. Deceased, whole organ vs. Split, one staged vs. Two staged) used to perform a standard liver transplant procedure for recipients with CRLM. Investigators will look at things like different procedure results, recovery in the hospital, and survival rates one year after the transplant. Investigators will also take blood samples from participants to be used in future research. All the transplant methods the investigators are comparing are standard practices approved by the United Network of Organ Sharing (UNOS).

Recruiting

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Key information

Conditions

Liver Transplant Surgery Colon Cancer Liver Metastases Colonic Diseases Colorectal Cancer Metastatic Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Northwestern University-Comprehensive Transplant Center

Chicago, Illinois, 60611, United States

Location status: Recruiting

Location contact

Yajaira Navarro

CONTACT

[email protected]

312-694-2092

Zachary Dietch, MD, MBA

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion:

  • All Patients of either gender ≥ 18 years of age who are listed for Liver transplant candidates at Northwestern with liver metastases due to colorectal cancer (CRLM).
  • Subjects must be able to provide informed consent themselves and without the use of a legally authorized representative (LAR), to be determined by the PI or Sub-I at the time of Consent.

Exclusion:

  • Adults unable to consent
  • Pregnant Women
  • Certain clinical/surgical/anatomical parameters, at the discretion of the PI.

Treatment and study plan

Primary outcomes

  1. Graft and Patient Survival Outcomes

    Time frame: From liver transplant to 12 months

    Graft survival will be measured as the time from transplantation to graft failure, or re-transplantation date.

Secondary outcomes

  1. Outcomes of liver transplant recipients

    Time frame: From liver transplant to 12 months

    Evaluate outcomes (e.g., complications or surgical outcomes) of liver transplant (LT) recipients.

Study contacts

Contact information is provided by the study sponsor or research team.

Yajaira Navarro

CONTACT

[email protected]

312-694-2092

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

Colorectal Metastasis to Liver Extraction With Auxiliary Transplant and Delayed Resection Registry Study

Acronym: CLEAR

Important dates

Study start
2025
Primary completion
2034
Study completion
2035
First posted
Nov 20, 2024
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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