Clinical trial for Colon Adenocarcinoma
Official title Family Communications After Genetic Testing
ClinicalTrials.gov ID: NCT07143487
What this study is testing
- What it's testing
- The study wants to find out whether having a health‑care provider tell relatives about genetic risk leads to more relatives getting tested, compared with patients telling their own family members.
- Who it's for
- People who have just been diagnosed with colorectal cancer and have a known inherited cancer‑risk gene, and their first‑degree relatives.
- What's involved
- Participants will be assigned to either the usual method where the patient shares the genetic test results with family, or a method where a health‑care provider contacts the relatives directly. The study includes counseling sessions and follow‑up calls to discuss the results and testing options.
- Time commitment
- The study lasts a few months and involves a few clinic visits or phone calls to deliver the information and check on testing.
- 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+).
- 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).
- 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 is enrolling
- Birmingham, Alabama, United States
- 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
- Cameron Park, California, United States
- Carmichael, California, United States
- Chico, California, United States
- Elk Grove, California, United States
- Marysville, 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
+ 253 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, but 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?
This study is enrolling now at Birmingham, Alabama, United States; Anchorage, Alaska, United States; Fairbanks, Alaska, United States; Phoenix, Arizona, United States; Fort Smith, Arkansas, United States; Little Rock, Arkansas, United States and 267 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.