Breast Cancer Trial, Recruiting NCT07038785 Sponsor: SpotitEarly Condition: Breast Cancer
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Breast Cancer Trial, Recruiting

NCT07038785
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

Arm 1 (Target Population Group):

  • People who are able to give their own informed consent and agree to follow the study requirements
  • People who were assigned female at birth
  • People who are 40 years of age or older, OR
  • People between 18 and 39 years of age who carry certain gene variants linked to a high risk of breast cancer (such as BRCA1, BRCA2, PTEN, TP53, CDH1, STK11, ATM, CHEK2, BARD1, RAD51D, RAD51C, or PALB2), OR
  • People between 18 and 39 years of age who have a family history of breast or ovarian cancer, where at least one close relative (parent, sibling, or child) or two second-degree relatives (such as grandparents, aunts, or uncles) were diagnosed with breast or ovarian cancer before the age of 50
  • People who are already scheduled for their routine yearly breast cancer screening, which includes a mammogram, ultrasound, and MRI

Arm 2 (Enriched Group):

  • People who are able to give their own informed consent and agree to follow the study requirements
  • People who were assigned female at birth
  • People who are 40 years of age or older, OR
  • People between 18 and 39 years of age who carry certain gene variants linked to a high risk of breast cancer (such as BRCA1, BRCA2, PTEN, TP53, CDH1, STK11, ATM, CHEK2, BARD1, RAD51D, RAD51C, or PALB2), OR
  • People between 18 and 30 years of age who have a family history of breast or ovarian cancer, where at least one close relative (parent, sibling, or child) or two second-degree relatives (such as grandparents, aunts, or uncles) were diagnosed with breast or ovarian cancer before the age of 35
  • People who have received a BI-RADS® score of 4B on a recent breast imaging result (this is a scoring system used by radiologists to describe findings on breast scans — confirm with trial site)
  • People who are already scheduled to have a breast biopsy

Who may not be able to join:

  • People who have had a cancer diagnosis within the past year (note: people who have had a non-spreading skin cancer surgically removed may still be considered)
  • People who have received any cancer treatment within the past year
  • People who have taken part in another clinical study within the past 30 days
  • People who have had both breasts surgically removed, whether due to breast cancer or as a preventive measure related to breast cancer risk
  • People who have had a medical procedure involving the chest cavity or airways within the past two weeks, which could affect their ability to provide a normal breath sample as required by the study

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 19 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Phone: +972-54-456-0008

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
SpotitEarly
Registry
ClinicalTrials.gov
Start date
22 July 2025
Est. completion
1 June 2027

Where this trial is recruiting

🇮🇱 Israel 🇺🇸 United States

Primary endpoints

Test Performance Evaluation

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 19 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov