Health TrialsbyHealthPanel

Feasibility Trial of Combination of Obstetrical Carrier Screening and Hereditary Cancer Screening

ConditionHereditary Cancer Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-55
SponsorColumbia University

About this trial

The investigators hypothesize that preconception and pregnancy may be a feasible and effective time to offer inherited cancer risk screening. This study will assess interest in cancer genetic testing among patients receiving routine prenatal care or preconception care. The goal is to evaluate the acceptability of hereditary cancer testing when offered alongside standard prenatal genetic screening. The study will also explore whether universal screening in this population could support early cancer prevention

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age: 18 years - 55 years

Patients receiving obstetrical-related care at a CUMC-affiliated enrollment site

Patients who have elected to undergo OCS with the CUMC-affiliated obstetrics provider

Patients with prior OCS but planned to repeat OCS are eligible

Disqualifiers

Patients who have previously completed a multigene hereditary cancer syndrome panel

Patients that have a hematologic cancer or hematologic pre-cancer

Patients who have a history of an autologous bone marrow transplant

Trial design

Design model

Parallel

Treatments tested in this trial

  • Natera empower comprehensive hereditary cancer panel

    Device

    Natera Empower Comprehensive Hereditary Cancer Panel to screen for hereditary cancers

  • Obstetrical carrier screening

    Device

    Obstetrical carrier screening for genetic conditions

Treatment groups

1,000 Participants
are divided into 2 treatment groups
Group A: Arm A: Hereditary cancer testingExperimental treatment 2 interventions
Group B: Arm B: No hereditary caner testingActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percentage of Participants Who Complete Both HCS and OCS

The percent of patients who complete hereditary cancer screening (HCS) when offered in addition to routine obstetrical carrier screening (OCS) during preconception and obstetrical-related care.

Time frame
Approximately at the end of recruitment, expected at 2 years

Secondary outcomes

1

Score on Regret About Healthcare Decisions survey

Participant experience with combined HCS and OCS will be assessed using a validated Regret About Healthcare Decisions Survey. The minimum score is 0 (lowest regret) to 100 (highest regret).

Time frame
2 to 6 months after enrollment
2

Score on Regret About Healthcare Decisions Survey among pregnant participants

Assessment of participant experience with combined OCS and HCS in pregnant participants using Regret About Healthcare Decisions Survey and qualitative interviews. The minimum score is 0 (lowest regret) to 100 (highest regret).

Time frame
Approximately at the end of recruitment, expected at 2 years
3

Score on Regret About Healthcare Decisions Survey among nonpregnant participants

Assessment of participant experience with combined OCS and HCS in nonpregnant participants using Regret About Healthcare Decisions Survey and qualitative interviews. The minimum score is 0 (lowest regret) to 100 (highest regret).

Time frame
Approximately at the end of recruitment, expected at 2 years
4

Hereditary cancer screening results

Number of pathologic variants identified by hereditary cancer screening.

Time frame
Approximately at the end of recruitment, expected at 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Columbia University

Lead sponsor

Natera, Inc.

Collaborator

Source ClinicalTrials.gov
Apply now