Clinical trial · Observational
InAdvance: Surveillance, Prevention, and Interception in a Population at Risk for Cancer
InAdvance: Surveillance, Prevention, and Interception in a Population at Risk For Cancer
NCT05463796CI-TRIAL-00122389recruitingClinicalTrials.gov clinicaltrialsProvenance
- 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)
This research study is creating a way to collect and store specimens and information from participants who may be at an increased risk of developing cancer, or has been diagnosed with an early phase of a cancer or a family member who has a family member with a precursor condition for cancer. * The objective of this study is to identify exposures as well as clinical, molecular, and pathological changes that can be used to predict early development of cancer, malignant transformation, and risks of progression to symptomatic cancer that can ultimately be fatal. * The ultimate goal is to identify novel markers of early detection and risk stratification to drive potential therapeutic approaches to intercept progression to cancer.
Conditions
Conditions (31)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenomatous Hyperplasia | — | UNRESOLVED | — |
| Adult Cancer Survivors | — | UNRESOLVED | — |
| Barrett Esophagus | — | UNRESOLVED | — |
| Benign Bone Lesions With Risk of Malignant Degeneration | — | UNRESOLVED | — |
| Cancer Predisposition Syndrome | — | UNRESOLVED | — |
| Cancer Risk | — | UNRESOLVED | — |
| Cervical and Endocervical Carcinoma in Situ | — | UNRESOLVED | — |
| Childhood Cancer Survivors | — | UNRESOLVED | — |
| Cirrhosis | — | UNRESOLVED |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Samples | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- label
- HEREDITARY RISK
- description
- Participants will also be asked to complete an intake survey that will include questions about demographics, medical history and family history data. Tissue samples will be collected during a routine visit. Participants will be asked to donate any of the following tissue types: * Blood * Buccal swab (saliva) or mouthwash * Urine * Stool * Biopsy or surgical tissue (i.e., bone marrow) * Bodily fluids * Other tissues
- interventionNames
- Other: Samples
- label
- EXPOSED HIGH RISK
- description
- Participants will also be asked to complete an intake survey that will include questions about demographics, medical history and family history data. Tissue samples will be collected during a routine visit. Participants will be asked to donate any of the following tissue types: * Blood * Buccal swab (saliva) or mouthwash * Urine * Stool * Biopsy or surgical tissue (i.e., bone marrow) * Bodily fluids * Other tissues
- interventionNames
- Other: Samples
- label
- PRECURSOR LESIONS
- description
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Participants to be included in this study include the following (note that this list is not comprehensive but gives examples of precursor conditions for each organ type): 1-Hereditary risk for cancer including * Carriers of known or previously unrecognized pathogenic germline variants of cancer predisposing genes * Individuals with personal or family history suggestive of elevated cancer risk (this may include individuals who have negative genetic testing results or have not elected to undergo testing) * Individuals with a clinically based diagnosis of a Cancer Predisposition Syndrome (examples, neurofibromatosis, Fanconi Anemia, Ataxia-Telangiectasia) * Hereditary Cancer Prediction Model-based elevated cancer risk * Others at risk for specific cancers by virtue of exposure, obesity, gender, race and ethnicity, HPV exposure (for H\&N cancer for example), etc. * Exposed High Risk including * Childhood cancer survivors with treatment exposures associated with increased risk of cancer * Adult cancer survivors with treatment exposures associated with increased risk of cancer * Documented high level exposure to group 1 IARC carcinogens * Thoracic: individuals at risk for lung cancer including but not exclusive of the following criteria: Age \>50, Smoking history of \>15 pack years, First-degree relative history of lung cancer or COPD * alcoholic liver disease (NAFL), non-alcoholic steatohepatitis (NASH), cirrhosis * Precursor Lesions including * Breast: ductal/lobular carcinoma in situ (CIS) and atypical hyperplasia * GI: Barrett's esophagus, Pancreatic precursor lesions, colonic dysplasia/adenomata, nonalcoholic fatty liver (NAFL), nonalcoholic steatohepatitis (NASH), cirrhosis * GU: High grade prostatic epithelial neoplasia, and high-grade bladder urothelial dysplasia/carcinoma in situ, * Lung: Adenomatous hyperplasia * H\&N: high-risk oral precancerous diseases * Skin: Class II melanocytic lesions. Squamous dysplasia * Heme malignancies: CHIP, CCUS, ICUS, MGUS, SMM, SWM, MBL (spell these out), Low grade lymphomas * Thoracic: Lung nodules detected on screening CT that prompt further follow-up * GYN: STIC lesion (serous tubal intraepithelial carcinoma), Endometrial intraepithelial neoplasia, Cervical and endocervical carcinoma in situ, vulvar intraepithelial neoplasia * Pediatric histologic diagnoses sometimes associated with development of malignancy: Nephrogenic rests, benign bone lesions with risk of malignant degeneration (Giant cell tumor, osteochondroma), Spitz nevus, and others. * FAMILY MEMBERS or healthy individuals Exclusion Criteria: There are no exclusion criteria for the study. Note: Patients with prior cancer history are allowed to participate. Patients with prior history of cancer or non-metastatic localized cancers (such as skin cancer or localized prostate cancer) are allowed to be enrolled. Patients enrolled in clinical trials or receiving therapy for precursor diseases are NOT excluded from this study.
References
Publications (2)
- BACKGROUNDKauffman TL, O'Donnell EK, Marinac CR, Babic A, Adams K, Beckwith JB, Berman TA, Brantley KD, Chowdhury D, Crompton BD, Diller LR, Elias KM, Feltmate CM, Florez N, Garber JE, Ghobrial I, Hanna GJ, Hormoz S, Kamihara J, LeBoeuf NR, Mittendorf EA, Partridge AH, Rodriguez NJ, Sands J, Thapa B, Weeks LD, Woo SB, Yurgelun MB, Parmigiani G, Rebbeck TR, Syngal S. A Longitudinal Comprehensive Biospecimen and Clinical Data Repository for Cancer Early Detection: The InAdvance Study. Cancer Epidemiol Biomarkers Prev. 2026 Jul 1;35(7):1076-1087. doi: 10.1158/1055-9965.EPI-25-1684. PMID 42059770
- DERIVEDO'Donnell EK, Kauffman TL, Asnis S, Kelly VA, Matthews E, Kartsounis M, Dharaneeswaran H, Beckwith JB, Bennett C, Marto M, Parmigiani G, Rebbeck TR, Ghobrial IM, Syngal S, Marinac CR. Diagnostic Outcomes among Patients with Positive Multi-Cancer Early Detection Test Results. Cancer Res Commun. 2026 Mar 1;6(3):511-515. doi: 10.1158/2767-9764.CRC-25-0723. PMID 41721625