Circulating Biomarkers in Patients With Anal Cancer Treated With Induction Chemotherapy

NCT05233540 | Unknown DMC

• 1 other identifier: DACG-III
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 3

Brief Summary

To investigate the prognostic and predictive value of plasma HPV (pHPV) prior, during and after induction chemotherapy (ICT) in locally advanced squamous cell carcinoma of the anus (SCCA) or synchronous metastatic SCCA patients treated with ICT prior to definitive (chemo)radiotherapy ((C)RT) according to multidisciplinary team (MDT) conferences based decisions. Further to investigate the use of pHPV measurements and other relevant markers for prediction of response and survival after ICT prior to definitive (C)RT.

Conditions

Anal Cancer; Locally Advanced Squamous Cell Carcinoma; Oligometastatic Disease; Circulating Tumor Cell; Human Papilloma Virus

Outcome Measures

Primary Outcomes (1)

• Overall survival according to circulating tumour DNA status

  Overall survival: Time from diagnosis to time of dead or date of last follow-up.

  2 year

Secondary Outcomes (3)

• Disease-free survival according to circulating tumour DNA and immune markers.

  2 year

• Recurrence-free survival according to circulating tumour DNA and immune markers.

  2 year

• Overall survival according to circulating tumour DNA and immune markers.

  2 year

Study Arms (1)

Locally advanced or synchronous metastatic anal cancer treated with induction chemotherapy

Patients with newly diagnosed anal cancer who by standard of care are eligible for induction chemotherapy prior to definitive CRT or radiotherapy alone (RT) will be screened according to inclusion- and exclusion criteria. Patients eligible for induction chemotherapy will be patients with locally advanced or synchronous metastatic anal cancer.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with newly diagnosed anal cancer who by standard of care are eligible for ICT prior to definitive CRT or radiotherapy alone (RT) will be screened according to inclusion- and exclusion criteria.

You may qualify if:

• Histological verified squamous cell carcinoma of the anus
• Treatment with ICT prior to definitive CRT or RT due to locally advanced disease or
• Patients with synchronous metastatic disease treated with ICT with the purpose of definitive CRT (potentially in combination with organ directed therapy (surgery, RFA, SBRT) for the metastatic sites)
• Age ≥ 18 years
• Written and orally informed consent

You may not qualify if:

• Contraindications for blood sampling
• Other malignancy within the past five years, with exception of basal cell carcinoma

Sponsors & Collaborators

• Aarhus University Hospital: lead

Study Sites (3)

Department of Oncology, Aarhus University Hospital

Aarhus, Aarhus N, 8200, Denmark

RECRUITING

Department of Oncology Herlev and Gentofte Hospital

Herlev, 2730, Denmark

NOT YET RECRUITING

Department of Oncology, Vejle hospital, University Hospital of Southern Denmark

Vejle, 7100, Denmark

NOT YET RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples and diagnostic biopsies

MeSH Terms

Conditions

Anus Neoplasms; Neoplastic Cells, Circulating

Condition Hierarchy (Ancestors)

Rectal Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Anus Diseases; Rectal Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Karen L Wind, MD

  Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karen L Wind, MD

CONTACT

20614431; karen.lycke.wind@auh.rm.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, principal investigator

Study Record Dates

• First Submitted: January 25, 2022
• First Posted: February 10, 2022
• Study Start: January 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 1, 2025
• Last Updated: February 10, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (3)