An Observational Research Study to Uncover Subtypes of Cancer Cachexia, LOTUS-CC Study (LOTUS-CC)
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ClinicalTrials.gov Identifier: NCT06073431 |
Recruitment Status :
Recruiting
First Posted : October 10, 2023
Last Update Posted : April 25, 2024
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Condition or disease |
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Cancer Cachexia (CC) |
PRIMARY OBJECTIVE:
I. To identify multiple distinct diagnostic subtypes within the syndrome of CC as defined by host characteristics (e.g. cachexia symptoms, physical activity, physical function, blood biomarkers including hemoglobin and albumin, and body composition) at baseline and change in these factors over time in patients with cancer at high risk for CC.
SECONDARY OBJECTIVES:
I. To determine the association of each CC phenotype with overall survival. II. To validate CC diagnostic phenotypes developed in a separate, independent cachexia observational study performed by our collaborators at Kaiser Permanente.
III. To collect human samples of blood, tumor tissue, and medical images and build a large, comprehensive CC database clinically annotated with cancer-related outcomes, cachexia symptoms, and physical function data.
EXPLORATORY OBJECTIVE:
I. To evaluate for tumor-derived factors contributing to CC by determining the association between interleukin-6 (IL-6) expression in tumors and IL-6 and CC chemokine ligand 2 (CCL2) levels in the blood in patients with CC.
OUTLINE: This is an observational study.
Patients complete surveys over 30 minutes, undergo physical function tests over 30 minutes, undergo collection of blood and archived tumor samples, and wear actigraphy over 24 hours for 7 days to record daily sleep and exercise activity at baseline and 3-month follow-up. Patients' medical records are also reviewed at baseline, 3-month and 1-year follow-up.
Study Type : | Observational |
Estimated Enrollment : | 800 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Longitudinal Observational Trial to Uncover Subtypes of Cancer Cachexia |
Actual Study Start Date : | December 4, 2023 |
Estimated Primary Completion Date : | January 1, 2028 |
Estimated Study Completion Date : | January 1, 2028 |
- Identification of multiple distinct diagnostic subtypes within the syndrome of cancer cachexia (CC) [ Time Frame: Baseline through study completion, assessed up to 1 year follow up ]Defined by host characteristics (e.g. cachexia symptoms, physical activity, physical function, blood biomarkers including hemoglobin and albumin, and body composition) at baseline and change in these factors over time in patients with cancer at high risk for CC. First, will examine the distributions of each variable and assess the need for using transformations to achieve normality for continuous variables (log transformation, quartiles, or clinically important thresholds), collapsing similar variables into single categories, and excluding g conditions that are too rare (< 1% of the cohort). Next, will assess statistical correlations using the Jaccard similarity metric for binary variables and the Pearson correlation for continuous variables to determine highly correlated variables that may provide redundant information.
Biospecimen Retention: Samples With DNA
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
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• Have a primary diagnosis of unresectable or stage IV 1) non-small cell lung cancer (NSCLC), 2) pancreatic adenocarcinoma, or 3) colorectal cancer
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Note: Patients do not need to have cachexia to be eligible
• Plan to start first-line systemic anti-cancer therapy (chemotherapy, immunotherapy, targeted therapy, interventional clinical trial) in the next 6 weeks or has started first-line systemic therapy in the previous 6 weeks.
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NOTE: Patients who received systemic anti-cancer therapy previously as part of adjuvant or neoadjuvant treatment and have since recurred are still eligible if such treatment ended > 6 months prior to enrollment. Patients receiving concurrent radiation with systemic therapy or receive local therapy alone (surgery, radiation therapy [RT]) prior to first line therapy remain eligible. Patients receiving maintenance treatment after first line therapy are not eligible
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
- Be able to understand, speak and read English
- Be 18 years of age or older
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Exclusion Criteria:
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• Have contraindications to physical function assessments (30-second arm curl, Timed-Up-And-Go test, or 30-second chair-stand test) per the treating provider or their designee
- Have any planned major surgeries within the next 3 months
- Have received chemotherapy or surgery for separate primary cancer within the past 3 years other than early local staged non-melanoma skin cancer
- Be pregnant
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06073431
Contact: Ashley Mack, MS | 585-275-1090 | URCC_22063@urmc.rochester.edu |
United States, Illinois | |
Carle Cancer Center NCORP (CARLE) | Active, not recruiting |
Urbana, Illinois, United States, 61801 | |
United States, Michigan | |
Cancer Research Consortium of West Michigan (CRCWM) | Active, not recruiting |
Grand Rapids, Michigan, United States, 49503 | |
United States, Ohio | |
Columbus NCORP (COLUMBUS) | Active, not recruiting |
Columbus, Ohio, United States, 43215 | |
United States, Wisconsin | |
Cancer Research of Wisconsin and Northern Michigan Consortium (CROWN) | Active, not recruiting |
Green Bay, Wisconsin, United States, 54301 | |
Aurora NCORP (AURORA) | Recruiting |
Milwaukee, Wisconsin, United States, 53226 | |
Contact: Neha Glandt 414-219-4718 neha.glandt@aah.org |
Study Chair: | Richard Dunne, MD, MS | University of Rochester NCORP Research Base |
Responsible Party: | Richard Dunne, Principal Investigator, University of Rochester NCORP Research Base |
ClinicalTrials.gov Identifier: | NCT06073431 |
Other Study ID Numbers: |
URCC-22063 OT2CA278664 ( U.S. NIH Grant/Contract ) |
First Posted: | October 10, 2023 Key Record Dates |
Last Update Posted: | April 25, 2024 |
Last Verified: | April 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | Currently, there is no plan to make individual participant data (IPD) available to other researchers. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Wasting Syndrome Cachexia Weight Loss Body Weight Changes |
Body Weight Thinness Metabolic Diseases Nutrition Disorders |