Clinical trial · Interventional
The Vanguard Study: Testing a New Way to Screen for Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The Vanguard Study is a feasibility study to explore several aspects of evaluating multi-cancer detection (MCD) tests in a future definitive randomized controlled trial. An MCD test measures markers in the blood in order to screen for multiple cancers simultaneously. There is a need to understand how MCDs may work as cancer screening tools. The goal of cancer screening is to reduce the burden of cancer by identifying cancers before they show symptoms or signs, when treatment is likely to be most effective. In this study, adults aged 45-75 without cancer will be randomly assigned to one of 3 groups: 2 separate MCD test groups or a control group. These two MCD tests will not be compared to each other but will be compared to cancers detected in the control group. This study will provide early information on how well MCD tests perform as cancer screening tools. It will also help researchers understand how patients and their doctors make decisions about their care when the MCD test result comes back as normal (negative) or abnormal (positive).
Conditions
Conditions (11)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Carcinoma | Bladder Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Breast Carcinoma | Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Colorectal Carcinoma | Colorectal Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Esophageal Carcinoma | Esophageal Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Gastric Carcinoma | Gastric Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Liver Carcinoma | Liver Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Lung Carcinoma | Lung Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Malignant Solid Neoplasm | Malignant Solid Neoplasm |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| Device Usage | Device | — | UNRESOLVED |
| Electronic Health Record Review | Other | — | UNRESOLVED |
| Multi-Cancer Detection Test | Procedure | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Arm I (Shield MCD test)
- description
- Participants undergo blood collection for Shield MCD testing at enrollment and after one year on study. Participants at unblinded sites are provided results of tests and those with abnormal results follow up with their clinician for additional testing. Participants at blinded sites are provided abnormal results and will follow up with their clinician for additional testing.
- interventionNames
- Procedure: Biospecimen Collection
- Device: Device Usage
- Other: Electronic Health Record Review
- Procedure: Multi-Cancer Detection Test
- Other: Questionnaire Administration
- type
- EXPERIMENTAL
- label
- Arm II (Avantect MCD test)
- description
- Participants undergo blood collection for Avantect MCD testing at enrollment and after one year on study. Participants at unblinded sites are provided results of tests and those with abnormal results follow up with their clinician for additional testing. Participants at blinded sites are provided abnormal results and will follow up with their clinician for additional testing.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 45 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Ages 45-75 years old * Agree to provide blood samples for possible MCD testing at enrollment and at 1 year following enrollment * Agree to allow collection of information from their medical records for study-related purposes * Understand and be able to complete informed consent and participant questionnaires in English, Spanish, or Arabic * Note: Eligibility for Spanish and Arabic languages are at the Hub's discretion Exclusion Criteria: * Solid malignant tumor or blood cancer diagnosis, with or without treatment, within the last 5 years * Note: Persons with a history of in situ cancers (e.g., ductal carcinoma in situ of the breast, cervical cancer in situ, atypical melanocytic hyperplasia or melanoma in situ) or nonmelanoma skin cancer are eligible. Persons with a history of prostate cancer that has not been treated are not eligible, regardless of when the diagnosis occurred * Ongoing cancer diagnostic work-up * Ongoing participation in another study of an investigational cancer screening test or technology not currently utilized in routine clinical practice * Currently breastfeeding or pregnant, or planning to become pregnant in the next year * History of solid organ or hematopoietic transplantation at any time, or blood transfusion within the last 30 days
References
Publications (1)
- DERIVEDGuthrie KA, Anderson GL, Bell-Brown A, Cook LS, Doescher MP, Etzioni RB, Feng Z, Henderson LM, Herman J, Honda SA, James AS, Kaltman R, Kooperberg C, Krist AH, Lee CB, Lee JK, LeeVan E, Liao JC, Minasian LM, Moore KN, Nana-Sinkam P, Natale KE, Neslund-Dudas C, Ngo-Metzger Q, Ong MJC, Oshiro CES, Park Y, Patriotis C, Pinsky P, Prorok PC, Reuland DS, Ritzwoller DP, Rubinstein WS, Sakoda LC, Sayles J, Schenk JM, Shofer S, Simoff M, Toriola AT, White L, Wion ES, Wood M, Ramsey SD. The vanguard study: Assessing feasibility of conducting randomized trials of novel multi-cancer detection tests. Contemp Clin Trials. 2026 Aug 9:108418. doi: 10.1016/j.cct.2026.108418. Online ahead of print. PMID 42571808