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New treatment option for Colon Adenocarcinoma
Official title Family Communications After Genetic Testing
ClinicalTrials.gov ID: NCT07143487
What this study is testing
- What it's testing
- This clinical trial compares patient (proband)-mediated communication to provider-mediated communication for improving genetic testing in first-degree relatives of patients with newly diagnosed colorectal cancer. It is estimated that 30% of cases of colorectal cancer have a genetic basis and about 15% of these patients have a disease-causing (pathogenic) inherited (germline) variant in a cancer susceptibility gene.
- Time commitment: about 3 years
- 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. Healthy volunteers may be eligible.
You may be able to join if
- STEP 1 PROBANDS: Age \>= 18 years
- STEP 1 PROBANDS: Patients with a newly diagnosed (within 3 months of registration), primary colorectal adenocarcinoma, stage I to IV
- Histologically proven stage I to IV colon or rectal adenocarcinoma (any T or N, M+). Tumors deemed to originate in the colon can extend into/involve...
- Patients with more than one primary colon adenocarcinoma are eligible
- STEP 1 PROBANDS: No patients with stage 0 or in-situ colorectal cancer
See the full eligibility criteria
- STEP 1 PROBANDS: Age \>= 18 years
- STEP 1 PROBANDS: Patients with a newly diagnosed (within 3 months of registration), primary colorectal adenocarcinoma, stage I to IV
- Histologically proven stage I to IV colon or rectal adenocarcinoma (any T or N, M+). Tumors deemed to originate in the colon can extend into/involve the small bowel (e.g., those at the ileocecal valve). Tumors will be...
- Patients with more than one primary colon adenocarcinoma are eligible
- STEP 1 PROBANDS: No patients with stage 0 or in-situ colorectal cancer
- STEP 1 PROBANDS: Patients who have had prior malignancies are eligible, including non-invasive cancers
- STEP 1 PROBANDS: Patients with synchronous second malignancies are eligible
- STEP 1 PROBANDS: Have not received germline testing in the 2 years prior to enrollment or known hereditary colon cancer syndromes
- STEP 1 PROBANDS: Patients must have at least 2 living FDRs who meet the eligibility criteria, with whom the patient is willing to share their cancer diagnosis
- STEP 1 PROBANDS: In order to complete the mandatory patient-completed measures and view the video and receive genetic education and counseling, participants must be able to speak and read English or Spanish
- STEP 1 PROBANDS: No known diagnosis of dementia or cognitive impairment. Persons with impaired decision-making capacity are ineligible as they need to be able to understand genetic test results, its implications for the...
- STEP 2 PROBANDS: Probands positive for a pathogenic germline variant (PGV) in a cancer susceptibility gene
- FDRs: Age \>= 18 years
- FDRs: Have not previously received germline genetic testing or known hereditary colon cancer syndromes
- FDRs: FDRs must reside within the United States, as genetic testing from LabCorp is only available to United States (U.S.) residents
- FDRs: In order to complete the mandatory patient-completed measures, participants must be able to speak and read English or Spanish
The study team makes the final eligibility decision.
Where it's taking place
- Anchorage, Alaska, United States
- Fairbanks, Alaska, United States
- Phoenix, Arizona, United States
- Fort Smith, Arkansas, United States
- Little Rock, Arkansas, United States
- Arroyo Grande, California, United States
- Burbank, California, United States
- Carmichael, California, United States
- Elk Grove, California, United States
- Merced, California, United States
- Napa, California, United States
- Rocklin, California, United States
- Sacramento, California, United States
- San Luis Obispo, California, United States
- Santa Maria, California, United States
- Santa Rosa, California, United States
- St. Helena, California, United States
- Stockton, California, United States
- Woodland, California, United States
- Colorado Springs, Colorado, United States
+ 187 more site(s).
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 study runs about 3 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Anchorage, Alaska, United States; Fairbanks, Alaska, United States; Phoenix, Arizona, United States; Fort Smith, Arkansas, United States; Little Rock, Arkansas, United States; Arroyo Grande, California, United States and 201 more location(s). Enter your location above to see the nearest site and check your eligibility.
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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.